Safety/tolerability, efficacy and pharmacokinetics of 600‐μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m 2 or higher: A phase I, randomized, double‐blind, placebo‐controlled study
Authors' conclusion
Cotadutide was well tolerated at doses up to 600 μg; efficacy versus placebo for weight loss and glycaemic control was shown.
Study context
- Population
- Japanese patients with T2D and BMI ≥25 kg/m²; all Asian, 62.5% male, median age 60 years, median BMI 27.2 kg/m²randomized 3:1
- Participants
- 16 patients
- Comparison
- Once-daily SC cotadutide vs placebo
- Cotadutiden = 12
- Placebon = 4reference
- Primary endpoint
- Safety, including treatment-emergent adverse events (TEAEs)
- Follow-up
- Through
Methodological detailsphase I, double-blind, placebo-controlled, dose escalation (Cohort 1), then Cohort 2
- Phase I
- Double-blind
- Placebo-controlled
- Dose escalation (Cohort 1), then Cohort 2
Primary result
As reported in the abstract
Patients with a TEAE
Secondary outcomes
7-day mean glucose by CGM · end of treatment (day 70)
Mean, %
| Outcome | Cotadutide | Placebo |
|---|---|---|
| Change in HbA1c | −1.13 (SD 0.64%) | −0.17 (SD 0.65%) |
| Percentage change in body weight | −6.93 (SD 3.44%) | −1.23 (SD 1.20%) |
7-day mean glucose by CGM · end of treatment (day 70)
- Significantly improved 7-day mean glucose with cotadutide
Safety
TEAEs · through follow-up
Treatment-emergent adverse events (TEAEs) · through follow-up
- No deaths, serious TEAEs or TEAEs leading to discontinuation
- Most common TEAEs: gastrointestinal-related
Original publication
Safety/tolerability, efficacy and pharmacokinetics of 600‐μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m 2 or higher: A phase I, randomized, double‐blind, placebo‐controlled study. Diabetes Obes Metab. Published 19 June 2023. doi:10.
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