Abstract
Aims: Most treatments for type 2 diabetes fail over time, necessitating combination therapy. We investigated the safety, tolerability and efficacy of liraglutide monotherapy compared with glimepiride monotherapy over 2 years.Methods: Participants were randomized to receive once-daily liraglutide 1.2 mg, liraglutide 1.8 mg or glimepiride 8 mg. Participants completing the 1-year randomized, double-blind, double-dummy period could continue open-label treatment for an additional year. Safety data were evaluated for the full population exposed to treatment, and efficacy data were evaluated for the full intention-to-treat (ITT) and 2-year completer populations. Outcome measures included change in glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and frequency of nausea and hypoglycaemia.Results: For patients completing 2 years of therapy, HbA1c reductions were −0.6% with glimepiride versus −0.9% with liraglutide 1.2 mg (difference: −0.37, 95% CI: −0.71 to −0.02; p = 0.0376) and −1.1% with liraglutide 1.8 mg (difference: −0.55, 95% CI: −0.88 to −0.21; p = 0.0016). In the ITT population, HbA1c reductions were −0.3% with glimepiride versus −0.6% with liraglutide 1.2 mg (difference: −0.31, 95% CI: −0.54 to −0.08; p = 0.0076) and −0.9% with liraglutide 1.8 mg (difference: −0.60, 95% CI: −0.83 to −0.38; p < 0.0001). For both ITT and completer populations, liraglutide was more effective in reducing HbA1c, FPG and weight. Over 2 years, rates of minor hypoglycaemia [self-treated plasma glucose <3.1 mmol/l (<56 mg/dl)] were significantly lower with liraglutide 1.2 mg and 1.8 mg compared with glimepiride (p < 0.0001).Conclusion: Liraglutide monotherapy for 2 years provides significant and sustained improvements in glycaemic control and body weight compared with glimepiride monotherapy, at a lower risk of hypoglycaemia.
Highlights
IntroductionMost antidiabetic agents fail to maintain longterm glycaemic control
As monotherapy, most antidiabetic agents fail to maintain longterm glycaemic control
Most antidiabetic agents fail to maintain longterm glycaemic control. This has been shown in the UK Prospective Diabetes Study (UKPDS) [1] and A Diabetes Outcome Progression Trial (ADOPT) [2] with either metformin, sulphonylurea (SU), or thiazolidinedione (TZD) monotherapy
Summary
Most antidiabetic agents fail to maintain longterm glycaemic control. Liraglutide is a once-daily glucagon-like peptide 1 (GLP-1) analogue for treatment of type 2 diabetes with 97% homology to human GLP-1. It is safe and effective when used alone or in combination with metformin [3,4,5], an SU [4,6], metformin + TZD [7] or metformin + SU [4,8]. At the 1.8 mg dose, liraglutide produced stable glycaemic control, with HbA1c levels unchanged at 52 weeks, as compared to the 12-week nadir
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