2024-513279-41-00CompletedPhase 2
A Phase 2 Parallel Group Study in Adults with Type 2 Diabetes to evaluate Efficacy and Safety of GL0034
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly s.c. Administered GL0034 in Adults with Type 2 Diabetes Mellitus Inadequately controlled on Metformin Or Diet and Exercise
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Nov 2025
Brief summary (registry, in English)
To investigate safety and tolerability of GL0034 with different titration algorithms over 16 weeks of treatment in people with type 2 diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 May 2024
- Start date
- 6 Sept 2024
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Diseases
- Type 2 diabetes
- EU CT number
- 2024-513279-41-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening
- Any additional oral anti-hyperglycemic drugs beyond metformin and/ or a SGLT-2-inhibitor within 3 months prior to screening
Other illness
- Were diagnosed with type 1 diabetes mellitus
- Had known allergies to GLP-1 analogs, GIP + GLP-1 analogs, glucagon, or related compounds
Lab values
- Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >5.65 mmol/L at screening and/or Day -1. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
Other
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Who the study is looking for
- Male and female patients 18 years to 70 years (both inclusive) of age on the day of signing informed consent
- Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent
- Have a glycated hemoglobin (HbA1c) value at screening of >= 6.5% and <=8.5% and treated with diet and exercise alone or a stable dose of metformin and/ or a SGLT-2-inhibitor for at least 3 months prior to screening
- Have a body mass index of >=28 to <=50 kilograms per square meter (kg/m²), both are inclusive
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | Germany | Completed |
| PROFIL Institut fuer Stoffwechselforschung GmbH | Neuss | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.