NCT00374907

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3 type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2011

Completed
Last Updated

May 7, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

September 7, 2006

Results QC Date

December 26, 2010

Last Update Submit

April 20, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12

    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.

    Baseline, Week 12

Secondary Outcomes (1)

  • Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12

    Baseline, Week 12

Other Outcomes (2)

  • Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period

    116 weeks

  • Marked Laboratory Abnormalities - During ST + LT Treatment Period

    116 weeks

Study Arms (2)

Saxagliptin (A)

EXPERIMENTAL

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

Drug: Saxagliptin

Placebo (ST) / Metformin (LT) (B)

PLACEBO COMPARATOR

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

Drug: PlaceboDrug: Metformin (blinded)Drug: Metformin (open-label)

Interventions

SaxagliptinDRUG

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

Also known as: BMS-477118
Saxagliptin (A)
PlaceboDRUG

Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)

Placebo (ST) / Metformin (LT) (B)
Metformin (blinded)DRUG

Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)

Placebo (ST) / Metformin (LT) (B)
Metformin (open-label)DRUG

Tablets, Oral, 500-1500 mg, as needed (starting in LT)

Placebo (ST) / Metformin (LT) (B)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Recent cardiac or cerebrovascular event
  • Elevated serum creatinine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Va San Diego Healthcare System

San Diego, California, 92161, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Diabetes & Glandular Disease Research Assoc,, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Boaz Hirschberg
Organization
AstraZeneca Pharmaceuticals
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Primary Completion

January 1, 2008

Study Completion

December 1, 2009

Last Updated

May 7, 2015

Results First Posted

January 21, 2011

Record last verified: 2015-03

Locations

US(3)