A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Recruiting
Phase 3
Interventional Study
Type 2 Diabetes
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 118 (estimated)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
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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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 …
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