A Phase 2 Parallel Group Study in Adults with Type 2 Diabetes to evaluate Efficacy and Safety of GL0034
Key facts
- Where
- Mannheim és Neuss, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- CRS Clinical Research Services Mannheim GmbHMannheim, NémetországNo longer taking part
- PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Pharmaceutical Industries Limited
- Trial code
- EU 2024-513279-41-00
- Record updated
- 2025. november 10.
- Original description
To investigate safety and tolerability of GL0034 with different titration algorithms over 16 weeks of treatment in people with type 2 diabetes.Read full original descriptionShow less
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
To investigate safety and tolerability of GL0034 with different titration algorithms over 16 weeks of treatment in people with type 2 diabetes.
Inclusion: 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.
Exclusion: 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; Were diagnosed with type 1 diabetes mellitus; Had known allergies to GLP-1 analogs, GIP + GLP-1 analogs, glucagon, or related compounds; 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; Women who are pregnant, nursing, or who plan to become pregnant while in the trial.