Safety/tolerability, efficacy and pharmacokinetics of 600‐μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m ²or higher: A phase I, randomized, double‐blind, placebo‐controlled study

Jun 20, 2023Diabetes, obesity & metabolism

Safety, effectiveness, and body processing of 600 µg cotadutide in Japanese type 2 diabetes patients with BMI 25 or higher: A phase I controlled trial

AI simplified

GLP-1 Therapies on OpenScience ↗PubMed ↗DOI ↗OA ↗

Abstract

91.7% of patients receiving cotadutide experienced treatment-emergent adverse events (TEAEs).

TEAEs were mostly mild, with only one moderate event reported.
No deaths or serious TEAEs occurred, and no patients discontinued due to TEAEs.
Cotadutide treatment resulted in a significant reduction in 7-day mean glucose levels compared to placebo.
Changes in HbA1c were greater in the cotadutide group than in the placebo group.
Patients treated with cotadutide experienced a mean weight loss of 6.93%, while the placebo group lost 1.23%.

AI simplified

AIM: To assess the safety/tolerability, efficacy and pharmacokinetics of once-daily, 600-μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/mor higher. 2

MATERIALS AND METHODS: This phase I, randomized, double-blind, placebo-controlled study (NCT04208620) enrolled patients to receive subcutaneous cotadutide at an escalating dose to determine the highest tolerated clinical dose (Cohort 1), then applied in Cohort 2. The primary endpoint was safety, including treatment-emergent adverse events (TEAEs); secondary endpoints included glycaemic control and body weight.

RESULTS: Sixteen patients were randomly allocated to receive cotadutide or placebo in a 3:1 ratio. All patients were Asian, 62.5% were male, and the median age and body mass index were 60 years and 27.2 kg/m, respectively. Through the follow-up period of the study, 11/12 (91.7%) patients in the cotadutide group experienced a TEAE versus 1/4 (25.0%) patients in the placebo group. All TEAEs were mild, except for one moderate event. There were no deaths, serious TEAEs or TEAEs leading to study discontinuation. Gastrointestinal-related events were the most common TEAEs. Cotadutide-treated patients achieved significantly improved 7-day mean glucose measured by continuous glucose monitoring; the 7-day mean (standard deviation) at the end of treatment (day 70) was 112.23 (20.79) versus 206.85 (3.62) mg/dL for placebo. Mean respective changes in HbA1c were -1.13% (0.64%) and -0.17% (0.65%); and mean percentage changes in body weight were -6.93% (3.44%) and -1.23% (1.20%). 2

CONCLUSIONS: Cotadutide was well tolerated at doses up to 600 μg; efficacy versus placebo for weight loss and glycaemic control was shown.

Full Text

Full text is available at the source.

View full text ↗

Safety/tolerability, efficacy and pharmacokinetics of 600‐μg cotadutide in Japanese type 2 diabetes patients with a body mass index of 25 kg/m ²or higher: A phase I, randomized, double‐blind, placebo‐controlled study

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief