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Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

NCT02273050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1136

Last updated 2018-02-05

Study results available
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Summary

A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control

Conditions

Interventions

DRUG

Saxagliptin 5 mg

Tablet, Oral, 5 mg, Once daily in the morning

DRUG

Placebo 5 mg for Saxagliptin

Tablet, Oral, 5 mg, Once daily in the morning

DRUG

Placebo 500 mg for metformin (with titration)

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

DRUG

Metformin 500 mg with titration

Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

Sponsors & Collaborators

Principal Investigators

  • Changyu Pan, Professor · The General Hospital of People's liberation Army

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

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Entities

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 NCT02273050 on ClinicalTrials.gov