Health TrialsbyHealthPanel

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

ConditionsType 2 Diabetes MellitusT2DM
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HM15275

    Drug

    HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes.

  • Placebo of HM15275

    Drug

    A sterile, matching solution supplied in pre-filled syringes.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: HM15275Experimental treatment 1 intervention
Group B: Placebo of HM15275Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glycated Hemoglobin (HbA1c)

Change in HbA1c (%) from randomization to Week 37.

Time frame
Up to 41 weeks

Secondary outcomes

1

Percentage of participants reaching specified HbA1c (%)

Percentage of participants reaching specified high, medium, and low HbA1c (%) after multiple subcutaneous (SC) doses.

Time frame
Up to 41 weeks
2

Number of participants with adverse events (AEs)

Number of participants with adverse events (AEs) after multiple subcutaneous (SC) doses.

Time frame
Up to 41 weeks

Other outcomes

1

Plasma concentration profile

Plasma concentration profile of HM15275 after multiple subcutaneous (SC) doses.

Time frame
Up to 41 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanmi Pharmaceutical Company Limited

Lead sponsor

Source ClinicalTrials.gov
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