NCT03499704

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

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Celltrion Pharm, Inc. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is Alogliptin Benzoate and Pioglitazone Hydrochloride FDC. This study will assess the efficacy of pioglitazone or dapagliflozin in participants with type 2 diabetes mellitus. The study will enroll approximately 156 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups. * Pioglitazone 15 mg + Alogliptin 25 mg + Metformin \>=500 mg * Dapagliflozin 10 mg + Alogliptin 25 mg + Metformin \>=500 mg Based on investigators opinion at Week 12, if participant has HbA1c \>=7.5%, dose of pioglitazone can be titrated up to 30 mg. This multi-center trial will be conducted in Republic of Korea. The overall time to participate in this study is up to 36 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Pioglitazone + Alogliptin	Pioglitazone and Alogliptin FDC tablets
DRUG	Alogliptin	Alogliptin tablets.
DRUG	Metformin	Metformin tablets.
DRUG	Dapagliflozin	Dapagliflozin tablets.

Timeline

• Start date: 2020-02-11
• Primary completion: 2024-01-02
• Completion: 2024-01-16
• First posted: 2018-04-17
• Last updated: 2026-03-18

Locations

15 sites across 1 country: South Korea