NCT00950599

Brief Summary

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
423

participants targeted

Target at P75+ for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started May 2003

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

May 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 23, 2010

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

July 31, 2009

Results QC Date

August 28, 2009

Last Update Submit

March 16, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort

    Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.

    Baseline, Week 12

  • Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort

    Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

    Baseline, Week 12

Secondary Outcomes (82)

  • Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts

    Baseline, Week 6

  • Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts

    Baseline, Week 6

  • Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort

    Baseline, Week 12

  • Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts

    Baseline, Week 6

  • Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort

    Baseline, Week 12

  • +77 more secondary outcomes

Study Arms (7)

Saxagliptin (2.5 mg)

EXPERIMENTAL
Drug: Saxagliptin

Saxagliptin (5 mg)

EXPERIMENTAL
Drug: Saxagliptin

Saxagliptin (10 mg)

EXPERIMENTAL
Drug: Saxagliptin

Saxagliptin (20 mg)

EXPERIMENTAL
Drug: Saxagliptin

Saxagliptin (40 mg)

EXPERIMENTAL
Drug: Saxagliptin

Saxagliptin (100 mg)

EXPERIMENTAL
Drug: Saxagliptin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SaxagliptinDRUG

Tablets, Oral, 2.5 mg, once daily, 12 weeks

Also known as: BMS-477118
Saxagliptin (2.5 mg)
PlaceboDRUG

Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes who are drug-naive
  • Screening HbA1c ≥ 6.8% and ≤ 9.7%
  • Screening fasting or random C-peptide \> 0.5 ng/mL
  • \< 35 years old must be negative for anti-GAD antibodies
  • Body Mass Index \< 35 kg/m2

You may not qualify if:

  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
  • Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
  • Significant cardiovascular history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.

    PMID: 18355324BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 3, 2009

Study Start

May 1, 2003

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

April 3, 2015

Results First Posted

February 23, 2010

Record last verified: 2015-03