Change In Hemoglobin A1c Research Articles

Changes in diabetes medications in the Diabetes and Periodontal Therapy Trial and their effect on hemoglobin A1c (HbA1c)

ObjectiveEvaluate the effect of medications and medication changes during the Diabetes and Periodontal Therapy Trial (DPTT) on the primary study outcome, namely, change in hemoglobin A1c (HbA1c) at 6months following baseline. MethodsThe DPTT set strict criteria for changes in diabetes medications. Medication change was defined as: change in dose of any 1 oral hypoglycemic agent by more than two-fold, change in dose of insulin of >10% and/or addition or subtraction of an oral hypoglycemic agent, insulin or non-insulin injectable agents. Comparisons between the treatment (non- surgical periodontal therapy) and control (no therapy) groups used t-tests for continuous variables and chi-square tests for categorical variables, including DPTT defined diabetes medication changes between baseline (BL) and 3month visits and 3- and 6-month visits. Changes in HbA1c were compared across the four medication change categories using ANOVA models, overall and for each treatment group separately. ResultsBaseline medication use was similar between the treatment groups (p>0.40), as were medication changes between BL- 3month visits and 3 and 6month visits (p=0.58). Participants with higher BL HbA1c (>8%) and those taking insulin at BL were more likely to have a change in medication (p=0.03). ConclusionsThe DPTT had the most rigorous definition of medication changes and medication monitoring of any trial in this field to date. The absence of a significant difference in medication changes between treatment groups may suggest that such changes did not play a role in the negative outcome of the DPTT.

Evaluating preferences for profiles of glucagon-like peptide-1 receptor agonists among injection-naive type 2 diabetes patients in Japan.

ObjectiveThe objective of this study was to use a discrete choice experiment (DCE) to estimate patients’ preferences for the treatment features, safety, and efficacy of two specific glucagon-like peptide-1 receptor agonists, dulaglutide and liraglutide, among patients with type 2 diabetes mellitus (T2DM) in Japan.MethodsIn Japan, patients with self-reported T2DM and naive to treatment with self-injectable medications were administered a DCE through an in-person interview. The DCE examined the following six attributes of T2DM treatment, each described by two levels: “dosing frequency”, “hemoglobin A1c change”, “weight change”, “type of delivery system”, “frequency of nausea”, and “frequency of hypoglycemia”. Part-worth utilities were estimated using logit models and were used to calculate the relative importance (RI) of each attribute. A chi-square test was used to determine the differences in preferences for the dulaglutide versus liraglutide profiles.ResultsThe final evaluable sample consisted of 182 participants (mean age: 58.9 [standard deviation =10.0] years; 64.3% male; mean body mass index: 26.1 [standard deviation =5.0] kg/m2). The RI values for the attributes in rank order were dosing frequency (44.1%), type of delivery system (26.3%), frequency of nausea (15.1%), frequency of hypoglycemia (7.4%), weight change (6.2%), and hemoglobin A1c change (1.0%). Significantly more participants preferred the dulaglutide profile (94.5%) compared to the liraglutide profile (5.5%; P<0.0001).ConclusionThis study elicited the preferences of Japanese T2DM patients for attributes and levels representing the actual characteristics of two existing glucagon-like peptide-1 receptor agonists. In this comparison, dosing frequency and type of delivery system were the two most important characteristics, accounting for >70% of the RI. These findings are similar to those of a previous UK study, providing information about patients’ preferences that may be informative for patient–clinician treatment discussions.

Diabetes and Depression Care: A Randomized Controlled Pilot Trial

We examined the comparative effectiveness of an integrated intervention for Type 2 diabetes mellitus (T2DM) and depression by employing patient prioritized planning (PPP) to incorporate patients' financial, social, and emotional needs versus an integrated intervention alone. A randomized controlled pilot trial randomly assigned 78 patients prescribed pharmacotherapy for T2DM in primary care to an integrated intervention for T2DM and depression employing PPP to incorporate patients' financial, social, and emotional needs (enhanced intervention) versus an integrated intervention alone (basic intervention). Hemoglobin A1C (HbA1C) assays measured glycemic control and the Center for Epidemiologic Studies Depression Scale (CES-D) assessed depression. Patients in the enhanced intervention had a significantly greater mean change in HbA1C from baseline in comparison with the basic intervention at 12 weeks (enhanced intervention -0.63 vs basic intervention 0.15; p = .027). Patients in the enhanced intervention also had a significantly greater mean change in CES-D from baseline in comparison with patients in the basic intervention group at 12 weeks (enhanced intervention -3.75 vs basic intervention 0.93; p = .041). Our pilot trial results indicate that an integrated care intervention employing PPP to incorporate financial, social and emotional needs for primary care patients with T2DM and depression may be effective.

Roux-En-Y Gastric Bypass Vs. Sleeve Gastrectomy: Balancing the Risks of Surgery with the Benefits of Weight Loss

BackgroundThe purpose of the study was to compare weight loss, metabolic parameters, and postoperative complications in patients undergoing Roux-en-Y gastric bypass (GB) and sleeve gastrectomy (SG).MethodsWe retrospectively studied 30-day postoperative complications as well as change in weight, blood pressure, cholesterol, hemoglobin, hemoglobin A1C, and creatinine from baseline to 2, 6, 12, and 24 months postoperatively in 383 patients undergoing GB and 336 patients undergoing SG at the University of Michigan from January 2008 to November 2013. For a study population which typically has high attrition rates, there were excellent follow-up rates (706/719 at 2 months, 566/719 at 6 months, 519/719 at 12 months, and 382/719 at 24 months).ResultsBaseline characteristics were similar in both groups except for higher weight and BMI in the SG group. The GB group experienced greater total body weight loss at 6, 12, and 24 months (41.9 vs. 34.6 kg at 24 months, p < 0.0001). Excess weight loss was 69.7 and 51.7 % following GB and SG respectively at 24 months (p < 0.0001). BP improved significantly in both groups. Surgical complication rates were greater after GB (10.1 vs. 3.5 %, p = 0.0007) with no significant difference in life-threatening or potentially life-threatening complications.ConclusionsWeight loss was greater following GB compared to SG at 2 years. The risk for surgical complications was greater following GB. Surgical intervention should be tailored to surgical risk, comorbidities, and desired weight loss.

A systematic review of commercial weight loss programmes' effect on glycemic outcomes among overweight and obese adults with and without type 2 diabetes mellitus.

We examined the glycemic benefits of commercial weight loss programmes as compared with control/education or counselling among overweight and obese adults with and without type 2 diabetes mellitus (T2DM). We searched MEDLINE, Cochrane Database of Systematic Reviews, and references cited by individual programmes. We included randomized controlled trials of ≥12 weeks duration. Two reviewers extracted information on study design, population characteristics, interventions, and mean changes in haemoglobin A1c and glucose. We included 18 randomized controlled trials. Few trials occurred among individuals with T2DM. In this population, Jenny Craig reduced A1c at least 0.4% more than counselling at 12 months, Nutrisystem significantly reduced A1c 0.3% more than counselling at 6 months, and OPTIFAST reduced A1c 0.3% more than counselling at 6 months. Among individuals without T2DM, few studies evaluated glycemic outcomes, and when reported, most did not show substantial reductions. Few trials have examined whether commercial weight loss programmes result in glycemic benefits for their participants, particularly among overweight and obese individuals without T2DM. Jenny Craig, Nutrisystem and OPTIFAST show promising glycemic lowering benefits for patients with T2DM, although additional studies are needed to confirm these conclusions. © 2016 World Obesity.

Insulin regimens, diabetes knowledge, quality of life, and HbA1c in children and adolescents with type 1 diabetes.

To further describe the changes in insulin therapy regimens and hemoglobin A1c (HbA1c) in children and adolescents with type 1 diabetes, and their associations with diabetes knowledge and quality of life. The study included 4293 children and adolescents (12.9 ± 2.6 yr, diabetes >1 yr) attending AJD (Aide aux Jeunes Diabétiques) summer camps between 2009 and 2014. The distribution of insulin regimens and associations between HbA1c, therapeutic regimens, diabetes knowledge (AJD questionnaire), and Quality of Life (Ingersoll et Marrero, Hvidoere Study Group short version) were assessed. The percentage of youth treated with insulin pumps increased up to about 45%, basal bolus stabilized around 40%, and other regimens decreased majorly. HbA1c was higher with premixed insulins only regimens (9.05 ± 2.43%), but there was no difference between pump (8.12 ± 1.09%), basal bolus (8.32 ± 1.33%) and two to three injections (8.18 ± 1.28%). Mean HbA1c decreased by 0.014% per year. The percentage of HbA1c <7.5% increased by 1.5% per year, and the percentages of HbA1c >9% or >10% decreased by 4 and 5.5%, changes being greater with the pump. HbA1c was weakly associated with diabetes knowledge, and strongly with general health perception and perception about diabetes. The percentage of children and adolescents with the highest risk of complications decreased markedly. The distribution of HbA1c better depicts the glycemic control in a population than the mean or the percentage of patients reaching the target (7.5%). HbA1c was more strongly associated with general health perception than with therapeutic regimens and diabetes knowledge.

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

Aims/IntroductionThe influence of overweight/obesity on the clinical efficacy and safety of sodium‐glucose co‐transporter 2 inhibitors is unclear. We carried out a pooled analysis to examine the impact of body mass index on the efficacy and safety of ipragliflozin.Materials and MethodsPatient‐level data were pooled for five Japanese double‐blind trials (NCT00621868, NCT01057628, NCT01135433, NCT01225081 and NCT01242215) in which patients were randomized to ipragliflozin or a placebo as monotherapy, or in combination with metformin, pioglitazone or a sulfonylurea. Outcomes included the changes in hemoglobin A1c, fasting plasma glucose, bodyweight and treatment‐emergent adverse events. Patients were divided into four body mass index categories.ResultsHemoglobin A1c, fasting plasma glucose and bodyweight decreased significantly in the ipragliflozin group compared with the placebo group in all body mass index categories, and in the total cohort (all P < 0.001). Hemoglobin A1c did not improve in 11.2 and 69.2% of patients in the ipragliflozin and placebo groups, respectively. The change in hemoglobin A1c was weakly correlated with the change in bodyweight in all patients (r = 0.136, P = 0.002). Regarding laboratory variables, the placebo‐subtracted difference tended to be greater in patients with higher body mass index for aspartate aminotransferase, alanine aminotransferase, γ‐glutamyl transpeptidase and uric acid. The incidences of treatment‐emergent adverse events were similar between the ipragliflozin and placebo groups in all patients combined and in the four body mass index categories.ConclusionsThese results show that the efficacy and safety of ipragliflozin are not influenced by obesity/overweight in Japanese patients.

Abstract P136: The Effect of Exercise Training on 10-Year Atherosclerotic Cardiovascular Disease Risk in Individuals with Type 2 Diabetes

Introduction: The American Heart Association (AHA) pooled cohort equations provide sex and race specific estimates of 10-year atherosclerotic cardiovascular disease (ASCVD) risk based on traditional risk factors, but not physical activity (PA) or fitness. The effect of exercise training on estimated ASCVD risk has not been previously evaluated, which is clinically relevant to individuals with type 2 diabetes (T2D) who have increased risk of ASCVD. The purpose of the present study is to determine the effect of aerobic (AER), resistance (RES) or combination (COMB) exercise training on 10-year ASCVD risk in individuals with T2D. Methods: The present study is an ancillary analysis of the Health Benefits of Aerobic and Resistance Training Study (HART-D). Adults with T2D (n=148) were randomized to 9 months of AER, RES, COMB exercise training or a control group (CON); 10-year ASCVD risk was calculated using the AHA pooled cohort equations based on each participants’ demographic (age, sex, race) and clinical data (high density lipoprotein, total cholesterol, systolic blood pressure/history of hypertension) and known T2D status at baseline and follow-up. Change in ASCVD risk was evaluated with an analysis of covariance with adjustment for baseline ASCVD risk. Results: Participants in the present analysis had a mean (SD) 10-year ASCVD risk of 12.2% (9.4). Baseline ASCVD risk was associated with body fat (r=-0.22, p&lt; 0.001) and duration of T2D (r=0.18, p=0.03), but not with peak VO 2 , hemoglobin A 1C , or other cardiometabolic variables (p&gt;0.05). No significant change in ASCVD risk was observed in the AERO (-0.36%, CI: -1.44 to 0.71), RES (-0.43%, CI: -1.49 to 0.63) and the COMB groups (-0.54%, CI: -1.57 to 0.49) compared to the CON (0.02%, CI: -1.26 to 1.31) group. However, in exercisers only, the change in diastolic blood pressure was associated with change in ASCVD (r=0.34, p&lt;0.001), but not change in hemoglobin A 1C , peak VO 2 , body fat mass, or other cardiometabolic risk factors (p&gt;0.05). Conclusions: The present study suggests that 9 months of exercise training did not reduce ASCVD risk predicted by the pooled cohort equations. Since exercise training is recommended by the AHA to reduce ASCVD risk especially in adults with T2D, future studies should evaluate if adding a variable that represents physical activity and/or fitness provides additional discrimination in the prediction of ASCVD.

Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial.

To demonstrate the effectiveness of a Diabetes Prevention Program-inspired 12-month behavioral intervention for patients with severe mental illness (SMI) and medication-associated obesity. This randomized, controlled, parallel, superiority study screened 225 volunteers from November 2005 to August 2008 at the VA Greater Los Angeles Healthcare System. 122 outpatients with DSM-IV-diagnosed SMI taking antipsychotic medications who had ≥ 7% weight gain or body mass index (BMI) > 25 were randomized by computer-generated number to Lifestyle Balance treatment intervention (n = 60) or usual care control (n = 62) groups. Clinical raters were masked to randomization. Treatment intervention included weekly classes and individual counseling for 8 weeks, food and exercise diaries, rewards, caregiver consultations, and monthly booster classes and counseling for 1 year. Controls received self-help materials and visited at equivalent intervals without formal classes or counseling. Outcomes were changes in anthropometric measurements, psychiatric symptoms, health knowledge, and glucose, hemoglobin A1c, and lipid levels. Our intention-to-treat analysis found significant differences in predicted trajectory of mean weight change between the groups over 12 months (P < .01), with treatment participants expected to lose an average 4.6 kg, while control participants would gain an average 0.6 kg. BMI and body fat percentage followed the same pattern. Both groups demonstrated statistically significant improvements in health knowledge quiz scores over time (P = .006), without significant difference between groups. Treatment was more effective than usual care control in treating medication-associated obesity, independent of SMI diagnosis, antipsychotic medication, and knowledge gained, suggesting that behavioral interventions are effective in SMI patients. ClinicalTrials.gov Identifier: NCT00344500.

Effects of different exercise programs and minimal detectable changes in hemoglobin A1c in patients with type 2 diabetes.

BackgroundThe incidence of diabetes mellitus is increasing worldwide, resulting in a global epidemic. The most common type, the type 2 diabetes mellitus, constitutes of 90–95 % of the cases and is characterized by the action of and/or impaired insulin secretion. Regular exercise is a recommended strategy in several studies and guidelines for type 2 diabetes control and complications associated with it. Therefore, we evaluated and compared the effects of aerobic and strength exercise programs on the glycemic control in patients with type 2 diabetes.MethodsThe selected patients were divided into groups which performed moderate strength training (ST) and aerobic training (AT). The study lasted 20 weeks and was divided into two 10 week phases with anthropometric (body mass index, waist, abdomen and hips circumferences, waist/hip ratio) and biochemical (glycemic and lipid profile) assessments at baseline, 10 weeks and 20 weeks. For intra and inter analyses a mixed ANOVA model was used. Individual changes were calculated using the minimum detectable change, based on a 90 % confidence interval.ResultsEleven patients (five men and six women) completed the 20 weeks of training; five from the ST group and six from the AT. No significant changes were observed in any anthropometric variable in either group. Statistically significant differences were found in mean hemoglobin A1c in both groups between baseline (AT: 8.6 ± 2.5; ST: 9.2 ± 1.9) and 10 weeks (AT: 7.2 ± 1.7; ST: 7.9 ± 1.2) (p = 0.03), and baseline (AT: 8.6 ± 2.5; ST: 9.2 ± 1.9) and 20 weeks (AT: 7.5 ± 1.7; ST: 7.4 ± 0.9) (p = 0.01). For the minimal detectable changes, 40 % of the ST and 33 % of AT achieved these changes for hemoglobin A1c.ConclusionBoth aerobic and strength exercises can help the metabolic control in patients with type 2 diabetes, even without significant changes in anthropometry over the 20 weeks of training. However, this period was sufficient to cause changes in hemoglobin A1c values and the estimated average glucose, which are important parameters in controlling diabetes, thus signaling an important consequence of adhering to an exercise routine for type 2 diabetic patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s13098-016-0123-y) contains supplementary material, which is available to authorized users.

Decreased serum betatrophin levels correlate with improved fasting plasma glucose and insulin secretion capacity after Roux-en-Y gastric bypass in obese Chinese patients with type 2 diabetes: a 1-year follow-up

BackgroundThere is increasing evidence that serum betatrophin levels, a hormone derived from adipose tissue and liver, are elevated in type 2 diabetes (T2D). ObjectiveTo investigate the relationships among betatrophin and metabolic control, insulin resistance, and pancreatic β-cell function in obese Chinese patients with T2D who underwent Roux-en-Y gastric bypass (RYGB). SettingUniversity hospital, China. MethodsThis 1-year follow-up study included 34 obese individuals with T2D (18 males, 16 females) who underwent RYGB in our hospital. Anthropometric results, glucose levels, lipid profiles, and serum betatrophin levels were determined before and 1 year after RYGB. ResultsThe serum betatrophin level decreased significantly after RYGB (72.0 ng/mL [33.4–180.9] versus 35.7 ng/mL [14.8–103.3]); P<.001]. The change in betatrophin was significantly positively correlated with the changes in hemoglobin A1c and fasting plasma glucose and negatively correlated with the changes in the 2-hour C-peptide/fasting C-peptide and homeostasis model of assessment of β-cell function (P<.05). Multiple stepwise regression analysis indicated that the change in the serum betatrophin level was independently and significantly associated with the changes in fasting plasma glucose (β = .586, P<.001) and 2-hour C-peptide/fasting C-peptide (β = –.309, P = .021). ConclusionCirculating betatrophin might be involved in the regulation of glucose control and insulin secretion in obese Chinese with T2D soon after RYGB.

Efficacy and safety of dapagliflozin in addition to insulin therapy in Japanese patients with type 2 diabetes: Results of the interim analysis of 16-week double-blind treatment period.

IntroductionDapagliflozin treatment when added to insulin therapy in Japanese patients with type 2 diabetes remains to be evaluated.Materials and MethodsThis was a multicenter, randomized, double‐blind, parallel‐group, placebo‐controlled study to evaluate efficacy (at 16 weeks) and long‐term safety (at 52 weeks) of dapagliflozin in addition to insulin therapy. The interim analysis was carried out at week 16 to assess the efficacy and safety profiles. The patients receiving insulin (n = 182) were randomized to either dapagliflozin 5 mg or a placebo at a 2:1 ratio. The primary efficacy end‐point was the change in hemoglobin A1c (HbA1c) from baseline at week 16.ResultsPatients in the dapagliflozin group showed an adjusted decrease in HbA1c of −0.55% from baseline, whereas the placebo showed a marginal increase of 0.05%. The placebo‐corrected mean change of HbA1c from baseline to week 16 in dapagliflozin was −0.60% (P < 0.0001). In addition, the placebo‐corrected mean change of fasting plasma glucose and bodyweight from baseline to week 16 in the dapagliflozin group was −22.7 mg/dL (P < 0.0001) and −1.21 kg (P < 0.0001), respectively. The placebo‐corrected mean daily insulin dose in the dapagliflozin group was numerically decreased (treatment difference: −0.72 IU/day; P = 0.0743). No major episodes or discontinuations as a result of hypoglycemia were reported during the study period.ConclusionsDapagliflozin used as add‐on treatment to insulin therapy showed significantly greater reduction of HbA1c, fasting plasma glucose and bodyweight without severe hypoglycemia compared with the placebo at week 16. These results show the clinical benefit of prescribing dapagliflozin for Japanese patients with insufficient glycemic control even with insulin therapy.

Pilot Study for the Development of a Self-Care System for Type 2 Diabetes Patients Using a Personal Digital Assistant (PDA).

The primary objective of the present pilot study was to investigate the feasibility and acceptability of the newly developed self-care system using personal digital assistance in patients with type 2 diabetes. The secondary objective was to investigate changes in daily calorie intake, body weight, and hemoglobin A1c after using the system for 6months. The participants were nine outpatients with type 2 diabetes, aged 34-72 and living in Tokyo or surrounding prefectures. They were instructed to use the electronic food diary and to review the graphs of the total energy intake to control food intake under their own target value for 6months. After they completed the study, the feasibility indicated by adherence rate for food recording and acceptability of the system rated with 6-point Likert scale from 1 (worst) to 6 (best) by the participants were investigated. Seven participants out of nine completed the study protocol. The median adherence rate for food recording was 80.6%. Regarding the acceptability, six patients rated 6 for desire to use the system while one rated 5. In addition, regarding improvement in self-care for diabetes, the median score was 5. Daily calorie intake, body weight, and HbA1c, however, did not change significantly over the 6-month period. The newly developed self-care system might be feasible and acceptable in diabetes patients, which could be applied as an ecological momentary intervention tool, although there was some room to refine it to raise adherence.

Comparison of Glycemic Control Indicators and Safety Evaluation during Linagliptin Treatment over 6 Months in Japanese Type 2 Diabetic Patients with and without Nephropathy

Objective: This retrospective study was undertaken to compare hemoglobin A1c and glycoalbumin levels as glycemic control indicators during linagliptin treatment in diabetic patients with or without nephropathy. The efficacy and safety of linagliptin were also examined. Methods: The subjects were 127 outpatients with type 2 diabetes, including 69 patients with nephropathy. The hypoglycemic effect of linagliptin and the factors contributing to its hypoglycemic effect were examined. Several clinical parameters were compared before and after the initiation of linagliptin to evaluate the drug’s safety. Results: Linagliptin significantly decreased hemoglobin A1c and glycoalbumin levels at 3 and 6 months after treatment initiation. At 6 months, changes in hemoglobin A1c levels from baseline were strongly correlated with changes in glycoalbumin levels in diabetic patients with and without nephropathy. Changes in hemoglobin A1c and glycoalbumin at 6 months were significantly greater in patients with higher baseline values and shorter diabetes duration. Linagliptin decreased both hemoglobin A1c and glycoalbumin levels, irrespective of the baseline estimated glomerular filtration rate. No changes in clinical parameters thought to indicate adverse events were noted. Conclusions: Glycoalbumin is an equivalent glycemic control indicator and predictor to hemoglobin A1c during linagliptin treatment. Linagliptin is safe and effective in diabetic patients with or without nephropathy.

Factor Analysis of Changes in Hemoglobin A1c After 12 Months of Sitagliptin Therapy in Patients With Type 2 Diabetes.

BackgroundSitagliptin, a dipeptidyl peptidase-4 inhibitor, is an effective oral antidiabetic agent as both monotherapy and when combined with insulin. Data from three observational studies performed in patients with type 2 diabetes receiving sitagliptin therapy in the routine clinical setting were integrated to conduct factor analysis of the changes in hemoglobin A1c (HbA1c), body weight, and estimated glomerular filtration rate (eGFR) over 12 months.MethodsAmong patients with type 2 diabetes attending medical institutions affiliated with Kanagawa Physicians Association, those using sitagliptin were followed for 1 year. In the ASSET-K and ASSIST-K studies, patients were managed by diabetologists, while they were managed by non-diabetologists in the ATTEST-K study. Patients were not administered insulin in ASSET-K, whereas insulin was administered in ASSIST-K. HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, and renal function (serum creatinine and eGFR) were the efficacy endpoints. Factor analysis was performed by analysis of variance using the magnitude of the change in HbA1c, body weight, and eGFR after 12 months of sitagliptin therapy as response variables, and the study, sex, and age as explanatory variables.ResultsOf 1,327 patients registered in ASSET-K (diabetologists/without insulin), 1,167 patients in ASSIST-K (diabetologists/with insulin), and 530 patients in ATTEST-K (non-diabetologists), statistical analysis was carried out on 1,074, 854, and 411 patients, respectively. There were significant inter-study differences in patient characteristics (complications, duration of diabetes, and baseline HbA1c), the sitagliptin dose, and the use of other antidiabetic agents. HbA1c decreased significantly in all three studies. According to factor analysis, the magnitude of the change in HbA1c over 12 months showed significant inter-study differences and was also significantly influenced by the age, duration of diabetes, and baseline HbA1c.ConclusionsComparison of three observational studies identified differences in patient characteristics, treatment of diabetes (use/non-use of insulin), and the level of specialist care (diabetologist/non-diabetologist). Despite such differences, consistent reduction of HbA1c by sitagliptin was demonstrated in all three studies. The patients showing most improvement in HbA1c with sitagliptin therapy were older patients with a short duration of diabetes and high baseline HbA1c level.

Factors Influencing Changes in Hemoglobin A1c and Body Weight During Treatment of Type 2 Diabetes With Ipragliflozin: Interim Analysis of the ASSIGN-K Study.

BackgroundIpragliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that blocks glucose reabsorption in the proximal tubules. SGLT2 inhibitors are expected to be effective in patients with insulin resistance and obesity, but it is important to select treatment according to patient background factors that minimizes the risk of adverse events. There have been a limited number of investigations into the relationship between the clinical efficacy (reducing hemoglobin A1c (HbA1c) and body weight (BW)) or safety of SGLT2 inhibitors and patient characteristics.MethodsASSIGN-K is an investigator-initiated, multicenter, prospective observational study examining the efficacy and safety of ipragliflozin (50 - 100 mg/day for 52 weeks) in Japanese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with HbA1c ≥ 6.0% (National Glycohemoglobin Standardization Program) despite diet and exercise therapy or diet and exercise plus antidiabetic drug therapy. We conducted an interim analysis of the relationship between changes in HbA1c or BW and characteristics in patients who had been on treatment for more than 12 weeks.ResultsIn 257 patients completing 12 weeks of treatment, HbA1c decreased significantly from 8.23% to 7.55% (-0.68%, P < 0.01). The change in HbA1c after 12 weeks was -0.17%, -0.33%, and -1.16% when baseline HbA1c was < 7%, 7% to < 8%, and ≥ 8%, respectively (P < 0.05, P < 0.01, and P < 0.01, respectively), and -1.30%, -0.62%, and -0.62% when baseline body mass index (BMI) was < 25, 25 to < 30, and ≥ 30, respectively (all P < 0.01). Stratified analysis showed that age, gender, or BMI did not have a significant influence on the improvement in HbA1c. Multiple regression analysis showed that reduction in HbA1c was greater as baseline HbA1c increased and the duration of diabetes decreased. A higher baseline HbA1c was associated with less weight loss.ConclusionsIpragliflozin significantly improved HbA1c in patients with T2DM. HbA1c improved more when baseline HbA1c was higher and the duration of diabetes was shorter, suggesting that current treatment policies for diabetes could be re-examined.

Plantar Pressure Changes and Correlating Risk Factors in Chinese Patients with Type 2 Diabetes: Preliminary 2-year Results of a Prospective Study.

Background:Plantar pressure serves as a key factor for predicting ulceration in the feet of diabetes patients. We designed this study to analyze plantar pressure changes and correlating risk factors in Chinese patients with type 2 diabetes.Methods:We recruited 65 patients with type 2 diabetes. They were invited to participate in the second wave 2 years later. The patients completed identical examinations at the baseline point and 2 years later. We obtained maximum force, maximum pressure, impulse, pressure-time integral, and loading rate values from 10 foot regions. We collected data on six history-based variables, six anthropometric variables, and four metabolic variables of the patients.Results:Over the course of the study, significant plantar pressure increases in some forefoot portions were identified (P < 0.05), especially in the second to forth metatarsal heads. Decreases in heel impulse and pressure-time integral levels were also found (P < 0.05). Plantar pressure parameters increased with body mass index (BMI) levels. Hemoglobin A1c (HbA1c) changes were positively correlated with maximum force (β = 0.364, P = 0.001) and maximum pressure (β = 0.366, P = 0.002) changes in the first metatarsal head. Cholesterol changes were positively correlated with impulse changes in the lateral portion of the heel (β = 0.179, P = 0.072) and pressure-time integral changes in the second metatarsal head (β = 0.236, P = 0.020). Ankle-brachial index (ABI) changes were positively correlated with maximum force changes in the first metatarsal head (β = 0.137, P = 0.048). Neuropathy symptom score (NSS) and common peroneal nerve sensory nerve conduction velocity (SCV) changes were positively correlated with some plantar pressure changes. In addition, plantar pressure changes had a correlation with the appearance of infections, blisters (β = 0.244, P = 0.014), and calluses over the course of the study.Conclusions:We should pay attention to the BMI, HbA1c, cholesterol, ABI, SCV, and NSS changes in the process of preventing high plantar pressure and ulceration. Some associated precautions may be taken with the appearance of infections, blisters, and calluses.

Short‐term and long‐term effects of dipeptidyl peptidase‐4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta‐analysis of randomized controlled trials

To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p < 0.0001] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd.

Evaluating preferences for profiles of GLP-1 receptor agonists among injection-naïve type 2 diabetes patients in the UK.

ObjectiveTo use a discrete choice experiment (DCE) to evaluate preferences for the actual treatment features and overall profiles of two injectable glucagon-like peptide-1 receptor agonists (dulaglutide and liraglutide) among patients with type 2 diabetes mellitus (T2DM) in the UK.MethodsIn-person interviews were conducted in the UK to administer a DCE to patients with self-reported T2DM, naïve to treatment with injectable medications. The DCE examined six attributes of T2DM treatment each described by two levels: “dosing frequency,” “hemoglobin A1c change,” “weight change,” “type of delivery system,” “frequency of nausea,” and “frequency of hypoglycemia.” Part-worth utilities were estimated using random effects logit models and were used to calculate relative importance (RI) values for each attribute. A chi-square test was used to determine differences in preferences for dulaglutide versus liraglutide profiles.ResultsA total of 243 participants [mean age: 60.5 (standard deviation 10.9) years; 76.1% male; mean body mass index: 29.8 (standard deviation 5.4) kg/m2] completed the study. RI values for the attributes in rank order were: “dosing frequency” (41.6%), “type of delivery system” (35.5%), “frequency of nausea” (10.4%), “weight change” (5.9%), “hemoglobin A1c change” (3.6%), and “frequency of hypoglycemia” (3.0%). Significantly more participants preferred the dulaglutide profile (83.1%) compared with the liraglutide profile (16.9%; P<0.0001).ConclusionThis study elicited patients’ preferences for attributes and levels representing the actual characteristics of two specific glucagon-like peptide-1 medications. In this context, dosing frequency and type of delivery system were most important, accounting for over 75% of the RI. While previous studies have identified efficacy as highly important in T2DM medication decisions, this study suggests that when differences in efficacy between medications are small, other treatment features (eg, dosing frequency and delivery system) are of much greater importance to patients.

Basal Insulin Regimens: Systematic Review, Network Meta-Analysis, and Cost - Utility Analysis for the National Institute For Health and Care Excellence (Nice) Clinical Guideline on Type 1 Diabetes Mellitus in Adults

To assess the clinical and cost-effectiveness of basal insulin regimens for adults with type 1 diabetes mellitus (T1DM), from the English National Health Service (NHS) perspective, and inform NICE recommendation regarding optimal choice of basal insulin. We considered seven daily insulin regimens: neutral protamine hagedorn (NPH) (once (od), twice (bid) and four-times daily (qid)), detemir (od and bid), glargine (od) and degludec (od). A systematic review of randomised controlled trials (RCTs) published in Medline, Embase and Cochrane databases to August 2014 was undertaken. Relative effectiveness was assessed using Bayesian network meta-analysis (NMA) undertaken in WinBUGs. Two outcomes were analysed: change in haemoglobin A1c (HbA1c) and rate of severe/major hypoglycaemia. The cost-utility analysis (CUA) was undertaken using the IMS-CORE Diabetes Model (IMS-CDM), following NICE reference case (lifetime time horizon, 3.5% discount rate for both costs and QALYs (quality-adjusted life-years), net monetary benefit (NMB) calculated using a threshold of £20,000 per QALY gained). Sensitivity analyses were performed; including changing insulin dose, discount rate and cost of hypoglycaemic events. Twenty eight RCTs were included in the NMA. The mean change in HbA1c ranged from -0.48% (SE=0.10) for detemir-(bid) to –0.01% (SE=0.17) for NPH-(qid). Mean rate of severe/major hypoglycaemia ranged from 29 (95%CI: 0.00 to 39.76) to 35 (95%CI: 0.00 to 46.73) events/100 person-years. The CUA showed that detemir-(bid) had the highest mean QALY-gain (11.09) and NMB (£181,456) per patient. Insulin glargine-(od) ranked second. Insulin degludec-(od) was the most costly, with the highest treatment cost (£7,169). The optimal choice was robust to all changes except when high doses of detemir-(bid) were assumed (>30% increment compared to other regimens); where glargine-(od) ranked first. Insulin detemir administered twice daily was the optimal basal regimen for adults with T1DM from the English NHS perspective; providing the highest QALY gain and NMB among the regimens considered.