GLPwatch
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
NCT01406717 · Completed
Last updated 2026-05-28This clinical trial tested the safety and effects of the medication SPIL1033 in adults with type 2 diabetes to see how it impacts blood sugar levels over time.
Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 360 people
Who can join Ages 20+ · all sexes
Timeline Started 2013-03 · est. completion 2015-11
Where 34 sites · India
What this study is testing ClinicalTrials.gov NCT01406717 ↗
Description as written by the study sponsor.
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033
Treatments tested
- SPIL1033 Drug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
- Placebo Drug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
| Main thing measured | Change From Baseline to End of Study in Hemoglobin A1c (HbA1c) |
|---|---|
| Sponsor | Sun Pharmaceutical Industries Limited |
| Conditions studied | Type 2 Diabetes Mellitus |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01406717 ↗