A 52-week International, Multicenter Trial with a Long -term Extension to Evaluate Saxagliptin with Dapagliflozin in combination with Metformin Compared to Glimepiride in Combination with Metformin in Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone

Study identifier:CV181-365

ClinicalTrials.gov identifier:NCT02419612

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin in combination with Metformin Compared to Glimepiride in Combination with Metformin ≥1500 mg in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Medical condition

diabetes

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin, Dapagliflozin, Glimepiride

Sex

All

Actual Enrollment

444

Study type

Interventional

Age

18 Years - 120 Years

Date

Study Start Date: 14 Aug 2015
Primary Completion Date: 29 Aug 2017
Study Completion Date: 18 Sept 2019

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria