GL0034 for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.
Are You a Good Fit for This Trial?
Adults over 18 with Type II diabetes for at least 6 months, HbA1c levels of 7.0-10.5%, and a stable BMI ≥27 kg/m2 can join this trial. They must be on metformin without other specific diabetes drugs for 3 months prior and agree to contraception if applicable.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- GL0034
Trial Overview
The study tests GL0034's effectiveness in managing Type II diabetes in overweight/obese adults compared to placebo. Participants receive weekly subcutaneous injections of either the drug or placebo after an initial dose-up titration period.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 6 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 4 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Dose Up-titration Period: Participants receive GL0034 starting at Dose Levels 1 to 3 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Dose Up-titration Period: Participants receive GL0034 starting at Dose Level 1 with titration up to Dose Level 2 for approximately 20 weeks Maintenance Treatment Period: Once participants reach their final designated doses, they will continue to receive the final designated doses by weekly subcutaneous administration until the end of Week 48.
Dose Up-titration Period: Participants receive sham placebo up titration, once weekly for approximately 20 weeks. Maintenance Treatment Period: Participants will continue to receive placebo once weekly through subcutaneous administration until the end of Week 48.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sun Pharmaceutical Industries Limited
Lead Sponsor
Dilip Shanghvi
Sun Pharmaceutical Industries Limited
Chief Executive Officer since 1993
Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor
Dr. Azadar H. Khan
Sun Pharmaceutical Industries Limited
Chief Medical Officer since 2023
MD from a recognized institution
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