Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes

This study is currently recruiting participants.

Verified July 2012 by Bristol-Myers Squibb

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01619059

First received: June 12, 2012

Last updated: February 22, 2013

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 12, 2012

Last Updated Date

February 22, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change from baseline in HbA1c at Week 24 [ Time Frame: Baseline (Day 1) and At Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01619059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline (Day 1) and at Week 24 ] [ Designated as safety issue: No ]
Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0% at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

Brief Summary

The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily, Up to 52 weeks

Other Name: Onglyza
Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
Drug: Metformin IR
Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks
Drug: Placebo matching with Saxagliptin
Tablets, Oral, 0 mg, Once daily, Up to 52 weeks

Study Arm (s)

Experimental: Arm 1: Saxagliptin+Dapagliflozin+Metformin IR
Interventions:
- Drug: Saxagliptin
- Drug: Dapagliflozin
- Drug: Metformin IR
Experimental: Arm 2: Placebo+Dapagliflozin+Metformin IR
Interventions:
- Drug: Dapagliflozin
- Drug: Metformin IR
- Drug: Placebo matching with Saxagliptin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

346

Estimated Completion Date

June 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic control Glycosylated hemoglobin (HbA1c) ≥ 8.0 and ≤ 11.5%
Stable dose of metformin for 8 weeks
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

Estimating Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2 or serum creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times the upper limit of normal (ULN)
Serum total bilirubin > 2.5 x ULN
Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
Cardiovascular disease within 3 months of the screening visit
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States, Canada, Czech Republic, Mexico, Poland, Romania, Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01619059

Other Study ID Numbers ^ICMJE

CV181-168, 2011-006323-37

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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