Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHanmi Pharmaceutical Company Limited
About this trial
This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.
Eligibility criteria
Qualifiers
United States: 18 to 75 years (inclusive)
Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
BMI ≥25 kg/m² and ≤50 kg/m²
Disqualifiers
Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
Poor glycemic control (fasting plasma glucose >270 mg/dL)
History of diabetic ketoacidosis or severe hypoglycemia within 6 months
Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
Trial design
Treatments tested in this trial
- HM15275
- Placebo of HM15275
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
10Arizona
Lenzmeier Family Medicine85308, Glendale United States
Desert Clinical Research85123, Mesa United States
Florida
AdventHealth Translational Research Institute32804, Orlando United States
Indiana
The South Bend Clinic46617, South Bend United States
Sponsors and collaborators
Hanmi Pharmaceutical Company Limited
Lead sponsor
Source ClinicalTrials.gov