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 groupsSponsors and collaborators
Source ClinicalTrials.gov