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Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin

NCT03608358 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-05-31

No results posted yet for this study

Summary

This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing hemoglobin A1c (HbA1c).

Conditions

Interventions

DRUG

Dapagliflozin 10 mg

10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 5 mg

5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 10 mg placebo to match

10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Dapagliflozin 5 mg placebo to match

5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

DRUG

Saxagliptin 5 mg

5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B

DRUG

Metformin

Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period

Sponsors & Collaborators

Principal Investigators

  • Linong Ji, Professor · People's Hospital of Peking Universty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2020-08-04
Completion
2020-08-04

Countries

  • Thailand
  • Vietnam

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03608358 on ClinicalTrials.gov