Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

Study identifier:CV181-014

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 3

Healthy volunteers

No

Study drug

Saxagliptin + Metformin, Placebo + Metformin, Pioglitazone

Sex

All

Actual Enrollment

1462

Study type

Interventional

Age

18 Years - 77 Years

Date

Study Start Date: 01 Aug 2005
Primary Completion Date: 01 Oct 2006
Study Completion Date: 01 Feb 2010

Study design

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

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria