Trial results for dulaglutide in participants with Type 2 Diabetes Mellitus in India were posted on ClinicalTrials.gov on 2025-02-05. The study reported that 51.9% of participants experienced adverse events and showed a mean reduction in HbA1c of -1.41% from baseline to Week 24.
Background
Dulaglutide is an established medication used in the management of Type 2 Diabetes Mellitus. This study specifically evaluated its safety profile in an Indian population.
Trial design
This completed Phase 4 trial (NCT05659537) enrolled 212 participants with Type 2 Diabetes Mellitus in India. The main purpose of the study was to evaluate the safety of dulaglutide in this specific population.
Key results
The key safety and efficacy results from the study are as follows:
- 51.9% of participants reported one or more adverse events (AEs) from baseline to Week 24.
- 0.5% of participants reported one or more serious adverse events (SAEs) from baseline to Week 24.
- A total of 1 participant experienced one or more serious adverse events.
- No deaths were reported.
- 13 participants experienced one or more hypoglycemic events, including severe hypoglycemic events.
- 48 participants experienced one or more gastrointestinal (GI) AEs from baseline to Week 24.
- The mean change in HbA1c from baseline to Week 24 was -1.41% with a standard deviation of 1.422.
What this means
The posted trial results provide important safety data for dulaglutide in participants with Type 2 Diabetes Mellitus in India. The reported adverse event rates, including 51.9% for AEs and 0.5% for SAEs, contribute to the understanding of the drug's safety profile in this specific demographic. The observed mean reduction in HbA1c of -1.41% also indicates the expected glucose-lowering efficacy of dulaglutide in this population, consistent with its established role in diabetes management.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05659537, titled "A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus in India," were posted on 2025-02-05 on clinicaltrials.gov.