A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy
NCT03499704 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133
Last updated 2026-03-18
Summary
The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Pioglitazone + Alogliptin
Pioglitazone and Alogliptin FDC tablets
- DRUG
-
Alogliptin
Alogliptin tablets.
- DRUG
-
Metformin tablets.
- DRUG
-
Dapagliflozin tablets.
Sponsors & Collaborators
-
Celltrion Pharm, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Team · Celltrionpharm Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-11
- Primary Completion
- 2024-01-02
- Completion
- 2024-01-16
Countries
- South Korea
Study Locations
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