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Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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ClinicalTrials.gov Identifier: NCT00316082
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : September 25, 2009
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

Condition or disease Intervention/treatment Phase
Diabetes Drug: Saxagliptin Drug: Placebo Drug: metformin Phase 3

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 in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Study Start Date : June 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
Experimental: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Experimental: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Experimental: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118

Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)

Placebo Comparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
Drug: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)

Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)




Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.


Secondary Outcome Measures :
  1. Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  3. Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.

  4. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.



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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Inadequate blood sugar control

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316082


  Show 74 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00316082     History of Changes
Other Study ID Numbers: CV181-038
First Posted: April 20, 2006    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: April 29, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action