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A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorHanmi Pharmaceutical Company Limited

About this trial

A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in patients with type 2 diabetes mellitus inadequately controlled with metformin and dapagliflozin

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Adults aged 19 years or older

2. Diagnosed with type 2 diabetes

3. HbA1c level 7.0% ≤ HbA1c ≤ 10.0%

4. Stable administration of metformin (≥1,000 mg/day) and dapagliflozin (10 mg/day) without any change in dosage or formulation for at least 8 weeks prior to Visit 1

Disqualifiers

1. Patients with a history of allergy or resistance to the investigational drug or background therapy

2. Patients diagnosed with a type of diabetes other than type 2 diabetes

3. Patients with uncontrolled severe diabetic complications

4. Patients with a history of acute or chronic metabolic acidosis, including lactic acidosis or diabetic ketoacidosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HM11260C

    Drug

    Test drug

  • Placebo

    Drug

    Placebo drug

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: HM11260CExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c at 36 weeks compared to baseline

Time frame
baseline, 36 weeks

Secondary outcomes

1

Change from baseline in HbA1c at Week 24

Time frame
baseline, 24 weeks
2

Proportion of subjects achieving HbA1c <7.0% at Weeks 24 and 36

Time frame
24, 36 weeks
3

Proportion of subjects achieving HbA1c <6.5% at Weeks 24 and 36

Time frame
24, 36 weeks
4

Change from baseline in FPG at Weeks 24 and 36

Time frame
baseline, 24, 36 weeks

Other outcomes

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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