The findings of this study suggest that in drug-naive patients, once-weekly taspoglutide improved glycaemic control, reduced body weight, and was generally well tolerated. Taspoglutide is a human glucagon like peptide 1 (GLP-1) analogue under development for the treatment of type 2 diabetes.

The study was designed as a 24 week, double blind, placebo controlled, multicentre trial. Patients were eligible for trial entry if they were adults (aged ≥18 and ≤80 years) with type 2 diabetes naive to anti-hyperglycaemic therapy and uncontrolled with diet and exercise (HbA1c 6.5-10%; BMI 25-45 kg/m2). Overall, patients were randomised in a 1:1:1 ratio to weekly subcutaneous taspoglutide 10mg (n=116) or 20 mg (n=129) or placebo (n=123). Of 373 randomised patients, 368 received at least one dose of study medication and had at least one follow-up safety measurement, and 354 received at least one dose of study medication and had an evaluable baseline and at least one post baseline measurement of HbA1c. The results found:

• HbA1c reductions from baseline were greater with taspoglutide 10 and 20 mg than placebo (least squares mean [SE] changes: –1.01% [0.07], –1.18% [0.06], and –0.09% [0.07], respectively; both P < 0.0001 vs. placebo).

• Decreases in bodyweight were greater with taspoglutide 10 mg (–1.45 kg [0.32]) and with 20 mg (–2.25 kg [0.30]) than placebo (–1.23 kg [0.31]; P = 0.61 and P = 0.02 for taspoglutide 10 and 20 mg vs. placebo, respectively).

• Gastrointestinal adverse events and injection site reactions were more common with taspoglutide than placebo.

Note: In September 2010, the company involved in the development of taspoglutide (Roche) stopped treatment with the drug in Phase III clinical trials, due to a higher than expected rate of discontinuations due to gastrointestinal (GI) intolerability and serious hypersensitivity reactions.