Efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes uncontrolled with sulphonylurea or sulphonylurea-metformin therapy: a randomized, double-blind study (T-emerge 6) Article

Industry Collaboration International Collaboration

cited authors

  • Pratley, R. E., Urosevic, D., Boldrin, M., Balena, R., T-emerge 6 Study Grp

funding text

  • The authors thank the T-emerge 6 study group, their staff and clinical trial personnel and subjects for participating in the study. We thank John Buse (University of North Carolina School of Medicine, Chapel Hill, NC, USA) for his contributions to the study design. Study investigators are listed in the supplemental online material. Funding for this study was provided by F. Hoffmann-La Roche AG, Basel, Switzerland. Support for third-party writing assistance for this manuscript, furnished by Susan M. Kaup, PhD, and Nick Brown, PhD, of UBC-Envision Group, was provided by F. Hoffmann-La Roche. R. E. P.: Consultant for Novartis, Eisai, Takeda, Merck, Mannkind, AstraZeneca/BMS, Roche, Sanofi-Aventis, GlaxoSmithKline, Lexicon and Novo Nordisk; board membership for Takeda; speakers' bureau for Merck (money paid to institution of employment); grants/grants pending from Novartis, Lilly, Takeda, Novo Nordisk, Mannkind, Roche, Sanofi-Aventis, GlaxoSmithKline and Pfizer (money paid to institution of employer). M. B. and D. U. are employed by F. Hoffman-La Roche. R. B. was employed at F. Hoffmann-La Roche at the time of this study. R. B. is currently affiliated with Eli Lilly and Company Ltd, Windlesham, Surrey, UK.

abstract

  • Aims This study compared the efficacy and tolerability of taspoglutide versus pioglitazone in subjects with type 2 diabetes inadequately controlled with sulphonylurea +/- metformin. Methods In this double-blind, double-dummy, parallel-group trial, 760 subjects (49% male, age 56.4?years, diabetes duration 8.8?years, body mass index 32.7?kg/m2 and haemoglobin A1c [HbA1c] 8.3%) were randomized (1:1:1) to subcutaneous injections of taspoglutide 10 or 20?mg once weekly or oral pioglitazone 45?mg daily. The primary endpoint was change in HbA1c after 24?weeks. Results Mean (+/- s.e.) HbA1c reductions with taspoglutide 10 (-1.18 +/- 0.08%) and 20?mg (-1.36 +/- 0.08%) were non-inferior to pioglitazone (-1.30 +/- 0.08%) (p?=?0.21 and 0.37, respectively); mean treatment differences were 0.12 (95% confidence interval: -0.03, 0.26) and -0.06 (-0.20, 0.08) for taspoglutide 10 and 20?mg versus pioglitazone. Mean (+/- s.e.) changes in body weight (kg) were -0.8 +/- 0.3, -1.0 +/- 0.3 and 3.6 +/- 0.3 for taspoglutide 10 and 20?mg and pioglitazone, respectively; 8, 11 and 1% of patients achieved >= 5% weight loss. A higher incidence of adverse events (AEs) occurred with taspoglutide, predominantly gastrointestinal disturbances and injection-site reactions, resulting in higher rates of discontinuation versus pioglitazone. No treatment differences in serious AEs were observed. Conclusions Taspoglutide offered good glycaemic control similar to pioglitazone, while achieving beneficial weight loss rather than weight gain, but was associated with more AEs. Due to the higher than expected discontinuation rates, mainly because of gastrointestinal intolerability, the taspoglutide clinical programme was stopped.

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Publication Date

  • March 1, 2013

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start page

  • 234

end page

  • 240

volume

  • 15

issue

  • 3

WoS Citations

  • 16

WoS References

  • 19