Significant Decrease In HbA1c Research Articles

PDB17 - REAL-WORLD DOSING BEHAVIOURS AND OUTCOMES WHEN SWITCHING TO IDEGLIRA FROM A FREE COMBINATION OF INSULIN AND GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONIST THERAPY

The real-world effectiveness of insulin degludec/liraglutide was demonstrated in EXTRA, a European, multicentre, retrospective chart review involving several baseline (BL) treatment regimens. This analysis examined changes in dosing behaviours and outcomes after IDegLira initiation in patients receiving separate injections of basal insulin and GLP-1RA therapy at BL. Data at BL (most recent measurement recorded in 6 months before IDegLira initiation) and follow-up (6 months ± 45 days after IDegLira initiation) from adults (N=89) with type 2 diabetes (T2D) who were receiving separate basal insulin/GLP-1RA injections ± oral antidiabetic drugs (OADs) were included. Analysis was performed for types of basal insulin/GLP-1RA received by >5% of patients (basal insulin, N=83; GLP-1RA, N=86; both used by >5% population [overall], N=81). At BL, basal insulins detemir, glargine 100 units/mL and degludec were used by 40%, 28% and 26% of patients, with liraglutide, exenatide and exenatide extended release being used by 83%, 9%, and 6% of patients, respectively. Mean daily basal insulin dose was higher at follow-up, as IDegLira, compared with BL, when administered separately, across all insulins; overall, mean (standard deviation [SD]) dose was 33.7 U (18.0) at baseline and 38.2 U (14.2) at follow-up. Mean daily GLP-1RA was lower at follow-up vs. BL with liraglutide and exenatide; overall, mean (SD) dose was 1.3 (0.7) and 1.1 (0.4) defined daily dose at baseline and follow-up, respectively. At follow-up, mean (SD) change from BL was –0.7% (1.2) for HbA1c (p<0.0001, N=81) and 0.3 kg (3.9) for body weight (p=0.5780, N=48). In patients receiving basal insulin + GLP-1RA ± OADs, switching to IDegLira in clinical practice results in a 13% overall increase in daily insulin component dose (+4.5 U), a 15% overall reduction in daily GLP-1RA component dose (–0.2 defined daily dose) and a significant decrease in HbA1c and no change in weight after 6 months.

Effects of meal replacement therapy on metabolic outcomes in Thai patients with type 2 diabetes: A randomized controlled trial.

Background:A meal replacement (MR) with a low glycemic index (GI) is possibly beneficial for glycemic control. However, the effects of MR on diabetes mellitus have not been studied among Thai patients with type 2 diabetes (T2DM).Aim:To compare metabolic outcomes between T2DM patients receiving the new MR formula (ONCE PRO) and normal controlled diets.Methods:A multicenter, open-labeled, randomized controlled trial was conducted. Eligible patients received either ONCE PRO for one meal daily with controlled diets or only controlled diets for 3 months. The differences in metabolic profile between the baseline and end point of each group and between groups were measured.Results:110 participants were enrolled; the mean difference and standard deviation in hemoglobin A1C (HbA1c) (%) from baseline were –0.21 ± 0.78 (p = 0.060) and –0.27 ± 0.60 (p = 0.001) in the MR and control groups, respectively; however, there was no significant difference between groups (p = 0.637). Patients consuming a MR instead of breakfast had a significant decrease in HbA1c (p = 0.040). Body weight (BW) and body mass index (BMI) were significantly reduced in both groups. There were no significant change in waist circumference, fasting plasma glucose, total cholesterol and triglycerides. Low-density lipoprotein cholesterol (LDL-C) was significantly decreased in the MR group compared with the control group (p = 0.049).Conclusions:Short-term conventional diet control and the low-GI MR product were associated with a decreased BW and BMI. Changes in the other metabolic outcomes, HbA1c, total cholesterol and triglycerides, were comparable despite ONCE PRO as the MR having a better effect on LDL-C lowering.

Efficacy and Safety of Initial Combination Therapy in Treatment-Naïve Type 2 Diabetes Patients: A Systematic Review and Meta-analysis.

IntroductionThe aim of this study was to evaluate the efficacy and safety of initial combination therapy compared with monotherapy in drug-naïve type 2 diabetes patients.MethodsMEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched for randomized clinical trials of initial combination therapy with hypoglycemic agents compared with monotherapy. Those which satisfied the search criteria were included in the meta-analysis. Weighted mean difference and relative risks were calculated.ResultsA total of 36 studies were included in the meta-analysis. Compared with metformin monotherapy, initial combination therapy with metformin plus another anti-diabetes drug exhibited significant reductions in glycated hemoglobin (HbA1c) (p < 0.001). Most of the combination therapies had a similar risk of hypoglycemia (p > 0.05), with the exception of combinations of sulfonylurea/glinide and metformin or combinations of thiazolidinedione and metformin. Compared with dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy, initial combination therapy with DPP-4 inhibitor plus another anti-diabetes drug showed a significant decrease in HbA1c (p < 0.001) and a similar risk of hypoglycemia (p > 0.05). Compared with monotherapy with other anti-diabetes drugs, initial combination therapies also resulted in significant HbA1c reductions, a similar risk of hypoglycemia and similar risks of other adverse events.ConclusionCompared with monotherapy, all initial combination therapies resulted in significant HbA1c reductions. Compared with metformin monotherapy, initial combination therapies with DPP-4 inhibitors plus metformin, sodium/glucose cotransporter 2 inhibitors and metformin, respectively, were associated with similar risks of hypoglycemia, but initial combination therapies with sulfonylurea plus metformin, thiazolidinedione and metformin, respectively, were associated with higher risks of hypoglycemia.FundingAstraZeneca Ltd. (China).Trial registrationRegistration number CRD42017060717 in PROSPERO.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0493-2) contains supplementary material, which is available to authorized users.

Disparities in the Efficacy of Metformin in Combination with Dipeptidyl Peptidase-4 Inhibitor as Initial Treatment Stratified by Dosage and Ethnicity: A Meta-Analysis.

As initial combination therapy of metformin and dipeptidyl peptidase-4 (DPP-4) inhibitor, the efficacy and safety for the use of high dose of metformin or low dose of metformin and the efficacy and safety for the combination use for Asian and Caucasian patients were not clear. Double-blind randomized controlled trials comparing the efficacy of initial combination therapy of metformin and DPP-4 inhibitors with metformin monotherapy were included. The primary outcome was a result of comparisons between high-dose combination therapy and low-dose combination therapy in terms of efficacy and safety. A total of 11 studies were included. The results indicated that the high-dose combination therapy showed significant decreases in hemoglobin A1c (HbA1c) (-0.32%, P < 0.05), fasting plasma glucose (FPG) (-0.63 mmol/L, P < 0.05), and postprandial glucose (PPG) (-0.99 mmol/L, P < 0.05), but less increase in body weight (-0.54 kg, P < 0.05) when compared with low-dose combination therapy, corrected by metformin monotherapy. Moreover, the high-dose combination therapy exhibited significant decreases in HbA1c (-0.24%, P < 0.05), FPG (-0.54 mmol/L, P < 0.05), and PPG (-0.94 mmol/L, P < 0.05) in the Caucasian population than in the Asian population, corrected by metformin monotherapy. As an initial treatment, the high dose of metformin in combination with DPP-4 inhibitors not only provided better glycemic control but also had less effect on weight gain compared with the low-dose combination therapy through the correction of metformin monotherapy. Moreover, initial combination therapy in the Caucasian population showed better glycemic control and less increase in body weight compared with the Asian population.

The Effect of Flash Glucose Monitoring on Glycemic Control in Patients with Type 1 Diabetes

Introduction: Freestyle Libre Flash glucose monitoring system is a new approach to self-monitoring of glucose. We investigated the effect on glycaemic control of applying this system in patients with type 1 diabetes in a real world clinical setting. Materials and Methods: A total of 210 consecutive patients with type 1 diabetes were included in an observational study investigating the change in glycaemic control upon introducing Freestyle Libre Flash Glucose monitoring (FGM) system (Abbott Diabetes Care Ltd, Range Road Witney, Oxon OX29 OYL; UK). Hba1c was monitored prior to the application of FGM and every 3-4 months during a follow-up of between 3 and 15 months. Results: HbA1C decreased significantly by 5 mmol/mol (IQR 10, P &amp;lt;0.0001) after 3 months as compared with baseline, where after HbA1c stabilized. When subdividing patients according to baseline glycemic control (Hba1c &amp;lt;53 mmol/mol, 54-70 mmol/mol, &amp;gt;70 mmol/mol) at inclusion in the study, we found a significant decrease in Hba1c in two groups (54-70: 4 mmol/mol, P&amp;lt;0.0001, &amp;gt;70: 7 mmol/mol, P&amp;lt;0.0001) from baseline to 3 months. Conclusion: In this observational study, we found a significant decrease in Hba1c- levels after the introduction of flash glucose monitoring in subjects with type 1 diabetes; this decrease was maintained throughout the 12-month study period. Disclosure G.H. Dørflinger: None. J.A. Østergaard: None. S. Fisker: Other Relationship; Self; Novo Nordisk A/S. S.T. Knudsen: Advisory Panel; Self; Novo Nordisk A/S, Merck &amp; Co., Inc., Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim GmbH, AstraZeneca. Speaker's Bureau; Self; Merck &amp; Co., Inc., Boehringer Ingelheim GmbH, AstraZeneca. T.K. Hansen: Advisory Panel; Self; Abbott, AstraZeneca, Novo Nordisk A/S. Research Support; Self; Novo Nordisk Foundation. Advisory Panel; Self; Merck Sharp &amp; Dohme Corp..

Accelerate the Self Understanding of Blood Glucose through the Summary Screen (ACCESS STUDY)

We previously assessed the effectiveness of a simple self-monitored blood glucose(SMBG) device with the function to display whether a blood glucose level is high or low in different colors (C device) (REFLECT STUDY, 2012 ADA), which reported that an interventional group using the C device and patient education materials showed a significant decrease in HbA1c compared to a group using a monochrome-display device. In our new ACCESS Study, we evaluated the effectiveness of a new SMBG device with an additional summary screen that shows past blood glucose patterns (device V) and a new educational material that advises on such blood glucose patterns. Outpaitients with diabetes mellitus (N=94, HbA1c 7.41 ± 0.85%) were randomly assigned to either an intervention group (N=50) where patients were switched from device C to device V with the new educational material, or to a non-intervention group (N=44) where patients were just switched from device C to device V and did not receive the new educational material. We evaluated the changes in HbA1c and patient satisfaction survey scores 8 weeks later. There was no significant difference in the change in HbA1c at 8 weeks between the intervention group (-0.06%; -0.165 to 0.045) and non-intervention group (-0.01%; -0.136 to 0.113). According to the results of the satisfaction survey, the intervention group showed a higher satisfaction in "Recognition of patterns/trends in blood glucose levels." There was a tendency in improvement of blood glucose pattern/trend recognition by patients by the intervention, there was no impact on HbA1c improvement. However, the outcomes of this study may have been affected by the short 8-week duration, as well as the fact that it was conducted during the period of seasonal change. Since device V and the new educational material improves blood glucose pattern/trend recognition, the results may have been different if a specific plan for blood glucose improvement tailored to each patient was further conveyed to each patient. Disclosure K. Suzuki: None. K. Hasegawa: None.

Disparity of the Efficacy of DPP-4 Inhibitors in Combination with Metformin vs. High Dose Metformin as Initial Treatment between Asian and Caucasian T2DM Patients

Background: To evaluate the efficacy and safety of DPP-4 inhibitors (DPP-4i) in combination with metformin as initial treatment vs. high or low dose of metformin in type 2 diabetes patients. Methods: Studies were identified by search of MEDLINE and EMBASE until Nov. 2017. Inclusion criteria were: T2DM; initial treatment; comparing metformin monotherapy vs.s DPP-4i in combination with metformin therapy; the primary endpoint was the change in HbA1c. Results: A total of 9 studies were included. In Asian drug-naïve T2DM patients, compared with high dose metformin monotherapy(2g/day), high dose metformin initial combine with DPP-4i therapy led to significant decrease in HbA1c (WMD -0.22%), while in Caucasian, combination therapy resulted in -0.53% change. The difference in the reduction of HbA1c between Asian and Caucasian of combination therapy vs. monotherapy was 0.31% with significance in favor of Caucasian population. In terms of fasting plasma glucose (FPG), in Asian patients, combination therapy vs. monotherapy led to -0.40mmol/L change, while in Caucasian, combination therapy vs. monotherapy led to -0.95mmol/L change. The difference in FPG reduction between Asian and Caucasian was 0.55mmol/L with significance in favor of Caucasian patients. The difference in postprandial glucose (PPG) reduction between Asian and Caucasian was 0.94mmol/L in favor of Caucasian. The difference in body weight changes between Asian and Caucasian was 0.50kg with significance body weight gain of Asian patients. Adverse effects were not increased when compared with combination therapy vs. monotherapy. Conclusion: DPP-4i with metformin as initial treatment was superior to metformin given alone in glycemic control of drug-naïve T2DM. The glucose-lowering efficacy of DPP-4i combination therapy was greater in Caucasian patients than in Asian. Disclosure X. Huang: None. X. Gao: None. X. Cai: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Eli Lilly and Company, Bristol-Myers Squibb Company, Novartis AG, Novo Nordisk A/S, Merck &amp; Co., Inc., Bayer AG, Merck Sharp &amp; Dohme Corp., Takeda Development Center Asia, Pte. Ltd., Sanofi, Roche Pharma, Boehringer Ingelheim GmbH. Research Support; Self; AstraZeneca, Roche Pharma, Sanofi, Merck Sharp &amp; Dohme Corp., Novartis AG, Eli Lilly and Company, Bristol-Myers Squibb Company.

The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial.

Probiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition. To assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications. In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24weeks. Anthropometric measurements, food record, physical activity and glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), fasting insulin levels (FIL), homoeostasis model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and β-cell function (HOMA-B) were assessed at baseline and repeated at 12 and 24weeks and compared within and between three groups using repeated measure ANOVA. Compared with the placebo, synbiotic supplementation resulted in a higher significant reduction in FPG (- 6.5 ± 1.6 vs. - 0.82 ± 1.7mg/dL, P = 0.01), FIL (- 2.6 ± 0.9 vs. - 0.8 ± 0.8 µIU/mL, P = 0.028), and HOMA-IR (- 0.86 ± 0.3 vs. - 0.16 ± 0.25, P = 0.007), and a significant elevation in the QUICKI (+ 0.01 ± 0.003 vs. + 0.003 ± 0.002, P = 0.006). In addition, significant decreases in HbA1C was seen following the supplementation of probiotics and synbiotic compared with the placebo (- 0.12 ± 0.06 and - 0.14 ± 0.05 vs. +0.07 ± 0.06%, P = 0.005 and 0.008, respectively). HOMA-B was not found to be different between or within the three groups. Glycemic improvement by probiotics and particularly synbiotic supplements in prediabetic individuals has been supported by current study. However, further studies are required for optimal recommendations in this important area of patient treatment. Iranian Registry of Clinical Trials: IRCT201511032321N2, Date registered February 27, 2016.

Efficacy and Safety of Long-Term Administration of Dapagliflozin for Japanese Patients with Type 2 Diabetes Mellitus

Background: There have been few studies yet on the efficacy and safety of SGLT2 inhibitor in Japanese people at 2 years and later. In this study, we administered dapagliflozin to Japanese patients with type 2 diabetes mellitus (DM) and studied its many effects and its safety. Subjects and Methods: The subjects were 112 patients aged 20 years and older who were administered 5 mg/day of dapagliflozin after outpatient treatment with dapagliflozin between April 2014 and December 2015 at this hospital had been judged as useful by the primary physician. Body weight (BW), systolic blood pressure (sBP), HbA1c, liver enzymes, HDL-cholesterol (HDL-C), and uric acid (UA) were measured during hospital visits, and these values were analyzed by comparing them between before administration and at 104 weeks of administration. Inbody® was used in 44 patients to compare body composition before and after treatment. Results: Dapagliflozin was administered over a period of 104 weeks, and a significant decrease in HbA1c, from 8.5±1.4% to 7.6±1.4% (week 0 vs. week 104, p&amp;lt;0.001), and a significant decrease in BW, from 82.2±19.3 kg to 78.6±18.9 kg (week 0 vs. week 104, p&amp;lt;0.001), were observed. sBP, UA, and liver enzymes also significantly decreased, and HDL-C significantly increased. When changes in body composition were checked with Inbody®, muscle mass and the amount of fat had both significantly decreased, but because of the large decrease in the amount of fat, the skeletal muscle index significantly increased. Also, the amount of the reduction in fat was significantly correlated with the amount of the decrease in HbA1c. Serious adverse drug reactions were not observed. Conclusion: Dapagliflozin can be safely administered over a period of 104 weeks to Japanese patients with type 2 DM, and effects such as lower blood sugar, reduced body weight, and improved metabolism can be expected. Also, a reduction in the amount of fat was suggested to be related to a reduction in HbA1c. Disclosure M. Yamazaki: None. R. Sakai: None. T. Okamura: None. M. Fukui: Research Support; Self; Grant-in-Aid for Scientific Research (C), Ono Pharmaceutical Co., Ltd., AstraZeneca, Astellas Pharma US, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kyowa Hakko Kirin Co., Ltd., Kissei Pharmaceutical Co., Ltd., MSD K.K., Novo Nordisk Foundation.

FGF21 decreases body weight without reducing food intake or bone mineral density in high-fat fed obese rhesus macaque monkeys.

Administration of FGF21 and FGF21 analogues reduce body weight; improve insulin sensitivity and dyslipidemia in animal models of obesity and in short term clinical trials. However potential adverse effects identified in mice have raised concerns for the development of FGF21 therapeutics. Therefore, this study was designed to address the actions of FGF21 on body weight, glucose and lipid metabolism and importantly its effects on bone mineral density (BMD), bone markers, and plasma cortisol in high-fat fed obese rhesus macaque monkeys. Obese non-diabetic rhesus macaque monkeys (five males and five ovariectomized (OVX) females) were maintained on a high-fat diet and treated for 12 weeks with escalating doses of FGF21. Food intake was assessed daily and body weight weekly. Bone mineral content (BMC) and BMD were measured by DEXA scanning prior to the study and on several occasions throughout the treatment period as well as during washout. Plasma glucose, glucose tolerance, insulin, lipids, cortisol, and bone markers were likewise measured throughout the study. On average, FGF21 decreased body weight by 17.6 ± 1.6% after 12 weeks of treatment. No significant effect on food intake was observed. No change in BMC or BMD was observed, while a 2-fold increase in CTX-1, a marker of bone resorption, was seen. Overall glucose tolerance was improved with a small but significant decrease in HbA1C. Furthermore, FGF21 reduced concentrations of plasma triglycerides and very low density lipoprotein cholesterol. No adverse changes in clinical chemistry markers were demonstrated, and no alterations in plasma cortisol were observed during the study. In conclusion, FGF21 reduced body weight in obese rhesus macaque monkeys without reducing food intake. Furthermore, FGF21 had beneficial effects on body composition, insulin sensitivity, and plasma triglycerides. No adverse effects on bone density or plasma cortisol were observed after 12 weeks of treatment.

Efficacy and safety of replacing sitagliptin with canagliflozin in real-world patients with type 2 diabetes uncontrolled with sitagliptin combined with metformin and/or gliclazide: The SITA-CANA Switch Study

AimTo analyze the efficacy and safety of replacing sitagliptin with canagliflozin in patients with type 2 diabetes (T2D) and poor metabolic control despite treatment with sitagliptin in combination with metformin and/or gliclazide. Materials and methodsIn this multicentre observational, retrospective, 26-week clinical study of patients with T2D and poor glycaemic control (HbA1c: 7.5–9.5%) treated with sitagliptin in combination with metformin and/or gliclazide, sitagliptin (and gliclazide if appropriate) were replaced by canagliflozin. The main outcome of the study was the proportion of patients who achieved good glycaemic control (HbA1c<7%) by the end of the study. ResultsThe study sample comprised 50 patients (baseline HbA1c 8.0±0.6%) treated with sitagliptin 100mg/day, 14 of whom were also taking gliclazide 60mg/day while 38 were taking metformin 1700mg/day. Sitagliptin treatment was replaced by either canagliflozin 100mg (n=17) or 300mg (n=33). After 26 weeks of follow-up, these patients presented with significant decreases in HbA1c (−1.1%; P<0.000), weight (−3.89kg; P<0.000), BMI (−1.37kg/m2; P<0.022), abdominal circumference (−5.42cm; P<0.004), systolic and diastolic blood pressure (−5.3mmHg and −4.4mmHg, respectively; P=0.005), triglycerides (−42mg/dL; P=0.005) and LDL/HDL cholesterol ratio (−0.34; P=0.005). By the end of the study, 42% of patients had achieved HbA1c levels<7%. ConclusionIn patients with T2D poorly controlled with sitagliptin, whether alone or in combination with metformin and/or gliclazide, replacing it with canagliflozin may be a simple yet effective intensification strategy. Our results, which may have important implications for clinical practice, now need to be confirmed in larger observational studies.

Relation of Iron Deficiency Anemia and the Level of Glycosylated Hemoglobin (HbA1c) in Non-Diabetic Patients

Introduction: The major form of glycohemoglobin is hemoglobin A1c (HbA1c). The Hb A1c fraction is elevated in chronic hyperglycemic diabetic patients and correlates positively with glycemic control. Previous studies suggest that iron deficiency anemia (IDA) affects the level of HbA1c. The aim of the study: To determine the effect of IDA on HbA1c level in non-diabetic patients before and after treatment with iron. Material and methods: The study included 100 females from Al jmail General Hospital at the west of Tripoli, 50 were with IDA and 50 were not anemic (control group). Age ranged from (20-40) years. Fasting blood glucose, HbA1c, complete blood count, serum iron, total iron binding capacity and serum Ferritin were measured in all females before treatment and after treatment. Patients who had glucose tolerance abnormality (impaired glucose tolerance or diabetes mellitus), hemoglobinopathy, hemolytic anemia, chronic alcohol ingestion, chronic renal disease, chronic liver disease and rheumatoid arthritis were excluded from study. All patients with IDA were treated with ferrous sulfate as 325mg orally three times a day for 3 months. Results: The mean percentage of the HbA1c in non-anemic patients control group was 5.2%. The mean percentage of HbA1c in patients with mild anemia was (6%), moderate anemia (5.9 %). In patients with severe anemia HbA1c was (3.2%) which is significantly low in comparison to normal females. After treatment with iron, significant increase in HbA1c was observed in patients with severe anemia (5.2%) p < 0.001 and significant decrease in HbA1c in female with mild and moderate anemia 5.2%,5.3% respectively P<0.001. Conclusion: In patient with iron deficiency anemia, hemoglobin A1c in not reliable parameter for follow up of patients with diabetes mellitus.

The effect of consumption of low glycemic index, high fat content bread on anthropometric measurement and cardiometabolic risk factors in women with type 2 diabetes mellitus

The aim of the present study was to examine the effects of consumption of breads with different glycemic index as part of a balanced diabetic diet on anthropometric and biochemical parameters in patients with type 2 diabetes mellitus. The study was conducted on 24 diabetic women who consulted the Dilovasi State Hospital Medicine Polyclinic; the patients had been diagnosed with type 2 diabetes with body mass index (BMI) ≥ 25 kg/m2 and were aged 40.29 ± 6.81 years. A total of 24 subjects with type 2 diabetes were randomized to consume one of two breads as part of their diets, consuming whole grain bread or wheat bread for 4 weeks. Both groups’ macronutrient distribution was planned so that about 45–65% of their calorie intake was from carbohydrates, 25–35% was from fat, and 15–20% was from protein. All food with glycemic response except bread was suggested similarly for both groups. Nutritional status, glycemic index values of foods, anthropometric values (weight, waist circumference, BMI, etc.), body composition, and biochemical analysis [fasting plasma glucose, fasting insulin, HbA1c, HOMA-IR, total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and C-reactive protein (CRP)] were measured at the beginning and the end of the study. Decrease in the average daily glycemic index in the whole grain bread group was 33.45 ± 9.72%, while it was 21.79 ± 5.97% in the bread made from whole wheat flour. The decrease in glycemic index was statistically significant. There was a significant reduction in body weight, BMI, and waist circumference in both groups, but differences between groups were not significant (p > 0.05). A statistically significant, positive relationship was found between decrease in glycemic index and decrease in waist circumference (r(22) = 0.46, p = 0.025). While there was a significant decrease in HbA1c in patients who consume whole grain bread, there was a significant decrease in insulin and HOMA-IR in those who consume wheat bread. There were no statistically significant changes in plasma glucose, HDL cholesterol, total cholesterol, and triglyceride levels (p > 0.05). There is a need to further research to determine the effects of breads with different glycemic indices on glycemic control in patients with type 2 diabetes.

Comparative efficacy and safety of DPP-4 inhibitors and α-glucosidase inhibitors as add on therapy in type 2 diabetes

Background: Diabetes mellitus (DM) is a spectrum of metabolic disorders as a consequence of different pathogenic mechanisms resulting in hyperglycemia. A genetic predisposition to develop β-cell dysfunction synergizes with insulin resistance to lead to type 2 DM. Adequate management of type 2 DM requires institution of non pharmacological treatment followed by pharmacological treatment. Monotherapy is started initially followed by combination therapy (dual/triple). Sitagliptin, a DPP-4 inhibitor and voglibose, an α-glucosidase inhibitor has been implicated as an add on therapy to metformin and glimepiride. So, we aimed to assess the efficacy and safety of the sitagliptin and voglibose as add on therapy to metformin and glimepitide in type 2 DM.Methods: This open label randomized control trial was conducted in the department of Pharmacology among patients attending medicine OPD of a tertiary care hospital. 80 patients were randomly divided into two groups of 40 patients each. group A:sitagliptin + metformin + glimepiride and group B:voglibose + metformin + glimepiride. Patients were followed every week for a period of 12 weeks. Data was analysed using paired t test, unpaired t test and chi square test.Results: There was a significant decrease in HbA1c, FPG and PPG in both the groups. Intergroup comparison at 4, 8 and 12 weeks showed a better improvement in glycemic control in group A as compared to group B.Conclusions: Sitagliptin showed a better glycemic control than that with voglibose in patients with uncontrolled type 2 DM on metformin and glimepiride.

Improving Population Health Among Uninsured Patients with Diabetes.

Diabetes is a leading cause of morbidity and mortality; prevalence of diabetes is especially high in the southeastern United States among minority populations and those from lower socioeconomic sectors without access to health care services. The purpose of this project was to evaluate the clinical and financial outcomes of a nurse-led, interprofessional collaborative practice model that provides care coordination and transitional care for uninsured patients with diabetes. Data for this study were collected and evaluated from medical records of patients seen at the Providing Access to Health Care (PATH) Clinic between August 1, 2015, through May 30, 2017. Clinical outcomes were evaluated by comparing hemoglobin A1c (HbA1c) values before and after referral to the PATH Clinic. Cost savings to the academic medical center were evaluated by comparing costs associated with inpatient or emergency department encounters before and after referral to the PATH Clinic. A significant decrease in HbA1c (P < .0005) was noted for patients attending the PATH Clinic. In addition, financial analyses revealed a 55% decrease in pre to post PATH Clinic patients' direct costs. Similarly, a 42% decrease in the pre to post PATH Clinic patients' direct cost per encounter was noted. Average length of stay also was reduced when these patients were readmitted to the academic medical center. Results from this study support the effectiveness of the PATH Clinic model in caring for uninsured patients with clinically complex medical and social needs, often with behavioral health problems, who incur high health care spending and are often readmitted.

Add-On Sitagliptin Therapy for Insulin-Treated Type 2 Diabetes: An Analysis of Hemoglobin A1c and Other Variables Using ASSIST-K Follow-Up Data

Background: Sitagliptin was the first dipeptidyl peptidase-4 (DPP-4) inhibitor approved in Japan. Its efficacy and safety have been demonstrated, both as monotherapy and in combination with oral antidiabetic agents or insulin. However, reduction of hemoglobin A1c (HbA1c) by sitagliptin is insufficient in some patients. Therefore, data from an observational study of sitagliptin as add-on therapy to insulin in patients with type 2 diabetes (ASSIST-K) were used to conduct factor analysis of the 12-month changes in HbA1c, body weight, estimated glomerular filtration rate (eGFR), and adverse events (AEs). Methods: At member institutions of Kanagawa Physicians Association specializing in diabetes, outpatients with type 2 diabetes receiving insulin were followed for 12 months after addition of sitagliptin. The HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, eGFR, and AEs were evaluated at each specified time. Multivariate analysis was performed by using sex and age as explanatory variables and the following response variables: the change in HbA1c, body weight, or eGFR after 12 months of sitagliptin treatment, and occurrence of AEs. Results: Of 1,168 patients registered in the ASSIST-K study, 412 patients were included in this analysis, excluding those not receiving insulin before sitagliptin, those in whom the 12-month change in HbA1c could not be calculated, and those with missing data on explanatory variables. There was a significant decrease in HbA1c and eGFR, but no significant change in body weight. AEs observed in > 10 patients were severe hypoglycemia (14 patients, 3.4%) and constipation (13 patients, 3.2%). Factor analysis revealed the following points: 1) Concurrent dyslipidemia and baseline HbA1c influenced the 12-month change in HbA1c; 2) Baseline body mass index and HbA1c influenced the 12-month change in body weight; and 3) Concurrent dyslipidemia, baseline sulfonylurea treatment, baseline body mass index, and baseline eGFR influenced the 12-month change in eGFR. In addition, the risk of severe hypoglycemia or constipation was significantly influenced by baseline HbA1c. Conclusions: Patients with type 2 diabetes showing higher HbA1c levels after add-on sitagliptin therapy had concurrent dyslipidemia and a lower baseline HbA1c. Severe hypoglycemia or constipation was more likely to occur in patients with a low baseline HbA1c. J Endocrinol Metab. 2018;8(6):126-138 doi: https://doi.org/10.14740/jem540

Weekly glucagon-like peptide-1 receptor agonist albiglutide as monotherapy improves glycemic parameters in Japanese patients with type 2 diabetes mellitus: A randomized, double-blind, placebo-controlled study.

Aims/IntroductionThe present phase 3, randomized, double‐blind 24‐week study with extension to 1 year assessed the efficacy and safety of albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus inadequately controlled by diet and exercise with or without a single oral antidiabetic drug.Materials and MethodsPatients received weekly albiglutide 30 mg (n = 160), albiglutide 50 mg (n = 150) or a placebo switched to albiglutide 30 mg after 24 weeks (n = 77). Open‐label daily liraglutide 0.9 mg (n = 103) was included as a reference. Oral antidiabetic drug use was discontinued before baseline. The primary end‐point was 24‐week change from baseline in glycated hemoglobin (HbA1c). Secondary end‐points included fasting plasma glucose, bodyweight and adverse events.ResultsAt 24 weeks, mean HbA1c changes from baseline were −1.10, −1.30, and 0.25% for albiglutide 30, 50 mg and placebo, respectively (P vs placebo <0.0001 for both albiglutide doses), −1.19% for liraglutide. Decreases in HbA1c with albiglutide were sustained through the study. Mean fasting plasma glucose decreased by ≥20 mg/dL, and the mean change in bodyweight was ≤0.5 kg through 1 year across groups. Most commonly reported adverse events were nasopharyngitis, constipation and nausea. The incidence of adverse events was higher in active treatment groups than in the placebo group. Few hypoglycemia events were reported; no patient withdrew as a result of hypoglycemia. No new safety signals were detected.ConclusionsAlbiglutide monotherapy achieved clinically significant decreases in HbA1c and fasting plasma glucose with good tolerability in Japanese patients with type 2 diabetes mellitus inadequately controlled by diet and exercise with or without a single oral antidiabetic drug.

An Effective Intervention for Diabetic Lipohypertrophy: Results of a Randomized, Controlled, Prospective Multicenter Study in France.

Background: Lipohypertrophy (LH) is highly prevalent and is potentially harmful to insulin-injecting patients.Methods: In this study, we assessed the impact of injection technique (IT) education, including use of a 4-mm pen needle on insulin-treated patients with clinically observed LH in a randomized, controlled, prospective multicenter study in France with follow-up of 6 months. Intensive education and between-visit reinforcement were given to the intervention group. Control patients received similar messages at study outset.Results: A total of 123 patients were recruited (age 52.1 ± 15.7 years; men 70.7%; body mass index >30 kg/m2: 34.2%; type 1: 53.7%; years with diabetes mellitus: 18.1 ± 10.5), of which 109 patients were included in the final analysis. The intervention group (n = 53) showed a significant decrease of total daily dose of insulin (average at baseline: 54.1 IU) at 3 months (T-3) and 6 months (T-6), reaching just over 5 IU versus baseline (P = 0.035). Corresponding, although not significant, decreases occurred in controls (n = 56); between-group differences were not significant. There were significant decreases in HbA1c (up to 0.5%) at T-3 and T-6 in both groups, with no significant differences between groups. A significant number of intervention patients improved their IT habits; about half achieved ideal IT habits by T-3 versus a quarter of control patients. By T-6, 2/3 of intervention patients achieved either ideal or acceptable IT habits, while only 1/3 of control patients did.Conclusions: Our intervention was effective in both study arms, however, to a greater degree and more rapidly in the intervention group. Widespread application of this intervention could be highly cost-effective.

Safety and Efficacy of The Available Oral Anti diabetic Drugs In Treating Type II Diabetics During Ramadan Fasting In Sohag Governorate.

Objective: to assess safety and efficacy of the available oral anti diabetic Drugs during Ramadan 2016 in Sohag Governorate . Methodology: This study was conducted on 90 type II Diabetic patients attending to outpatient Endocrinology clinic in Sohag University Hospital, on oral treatment classified into 5groups,as following , 20 (22.22%)patients on Metformin(Group I),30 (33.33%)patients on Sulphonylureas with or without metformin(Group II), 18 (20%) patients on Dipeptidyl peptidase-4 inhibitors with or without metformin (Group III),12 (13.33% ) patients on Thiazolidinedoines with or without metformin (Group V),10 (10%) patients on combinations of more than two drugs (Group VI), Mean age of patients is 59.93±7.87years, (61.11%)of them were females,(38.89%) of them were male patients and Mean duration of diabetes is 4.52±2.45(range 1:10).follow up of the patient was done by Wight changes, measuring blood sugar ,asses Hba1c ,and renal function also was done before and during ramadan. Results: In this study we found a significant decrease in Hba1c after Ramadan with Group III (DPP4I) compared with other Groups also we found the number of hypoglycemic episodes of all groups about 10 (11.11%), more with Group II (SUs) about (9) patients developed hypoglycemia of whom 30, compared with other groups while lower number of hypoglycemia was found with Group III (DPP4I),about one patient developed hypoglycemia, also we found the number of non fasted days more with SUs,(range 2-10) also we found no body weight changes more with Group III (DPP4I) while body weight gain occurred with Group II (SUs) about 1-4Kgs . In conclusion, Ramadan represents one of challenging issues for health care providaers all over the world . DPP4 inhibitors may considered favorable for use during and after Ramadan due to their lower rate of hypoglycemic events and weight neutral/loss effect during and after Ramadan .

The effect of 12 weeks carnosine supplementation on renal functional integrity and oxidative stress in pediatric patients with diabetic nephropathy: a randomized placebo-controlled trial.

Oxidative stress is a significant contributor to the pathogenesis of diabetic nephropathy. Carnosine is a natural radical oxygen species scavenger. We investigated the effect of carnosine as an adjuvant therapy on urinary albumin excretion (UAE), the tubular damage marker alpha 1-microglobulin (A1M), and oxidative stress in pediatric patients with type 1 diabetes and nephropathy. This randomized placebo-controlled trial included 90 patients with diabetic nephropathy, despite oral angiotensin-converting enzyme inhibitors (ACE-Is), who were randomly assigned to receive either 12 weeks of carnosine 1 g/day (n = 45), or matching placebo (n = 45). Both groups were followed-up with assessment of hemoglobin A1c (HbA1c), UAE, A1M, total antioxidant capacity (TAC) and malondialdhyde (MDA). Baseline clinical and laboratory parameters were consistent between carnosine and placebo groups (P > .05). After 12 weeks, carnosine treatment resulted in significant decrease of HbA1c (8.2 ± 2.1% vs 7.4 ± 1.3%), UAE (91.7 vs 38.5 mg/g creatinine), A1M (16.5 ± 6.8 mg/L vs 9.3 ± 6.6 mg/L), MDA levels (25.5 ± 8.1 vs 18.2 ± 7.7 nmol/mL) while TAC levels were increased compared with baseline levels (P < .001) and compared with placebo (P < .001). No adverse reactions due to carnosine supplementation were reported. Baseline TAC was inversely correlated to HbA1c (r = -0.58, P = .04) and A1M (r = -0.682, P = .015) among carnosine group. Oral supplementation with L-Carnosine for 12 weeks resulted in a significant improvement of oxidative stress, glycemic control and renal function. Thus, carnosine could be a safe and effective strategy for treatment of pediatric patients with diabetic nephropathy.