A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00374907

First received: September 7, 2006

Last updated: June 3, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2006

Last Updated Date

June 3, 2011

Start Date ^ICMJE

September 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Original Primary Outcome Measures ^ICMJE

Insulin at 12 week

Change History

Complete list of historical versions of study NCT00374907 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Original Secondary Outcome Measures ^ICMJE

Other measures of insulin secretion at 12 weeks
Levels of other hormones that affect blood sugar levels at 12 weeks

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Official Title ^ICMJE

Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

Brief Summary

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Detailed Description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Saxagliptin
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)

Other Name: BMS-477118
Drug: Placebo
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
Drug: Metformin (blinded)
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Drug: Metformin (open-label)
Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Study Arm (s)

Experimental: Saxagliptin (A)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Intervention: Drug: Saxagliptin
Placebo Comparator: Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Interventions:
- Drug: Placebo
- Drug: Metformin (blinded)
- Drug: Metformin (open-label)

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

Completed

Enrollment ^ICMJE

156

Completion Date

December 2009

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes mellitus
Drug naive
Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
Fasting C-peptide ≥1.0 ng/mL
Body mass index ≤40 kg/m²

Exclusion Criteria:

Recent cardiac or cerebrovascular event
Elevated serum creatinine

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00374907

Other Study ID Numbers ^ICMJE

CV181-041

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2011

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

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