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A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

NCT02681094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2018-10-10

Study results available
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Summary

The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.

Conditions

Interventions

DRUG

Dapagliflozin

5mg, orally, Green, plain, diamond-shaped, film-coated tablet

DRUG

Placebo for Dapagliflozin

Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet

DRUG

Saxagliptin

5mg, orally, Plain, yellow, biconvex, round, film-coated tablet

DRUG

Placebo for Saxagliptin

Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet

Sponsors & Collaborators

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
2016-02-26
Primary Completion
2017-07-15
Completion
2017-07-15

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Mexico
  • Russia

Study Locations

More Related Trials

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 NCT02681094 on ClinicalTrials.gov