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

Overview[ - collapse ][ - ]

Purpose The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Saxagliptin
Drug: Saxagliptin
Drug: Saxagliptin
Drug: Placebo matching Saxagliptin
Drug: Metformin
Drug: Placebo matching Metformin
Drug: Saxagliptin
Drug: Metformin
PhasePhase 3
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00121641
First ReceivedJuly 15, 2005
Last UpdatedAugust 5, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateJuly 15, 2005
Last Updated DateAugust 5, 2011
Start DateJuly 2005
Estimated Primary Completion DateFebruary 2010
Current Primary Outcome Measures
  • Hemoglobin A1c (A1C) Changes From Baseline at Week 24 [Time Frame: Baseline, Week 24] [Designated as safety issue: No]To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
  • A1C Changes From Baseline at Week 24 - Open Label Cohort [Time Frame: Baseline, Week 24] [Designated as safety issue: No]To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Current Secondary Outcome Measures
  • Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) [Time Frame: Baseline, Week 24] [Designated as safety issue: No]
  • Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 [Time Frame: Week 24] [Designated as safety issue: No]
  • Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) [Time Frame: Baseline, Week 24] [Designated as safety issue: No]
  • Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort [Time Frame: Baseline, Week 24] [Designated as safety issue: No]
  • Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort [Time Frame: Week 24] [Designated as safety issue: No]
  • Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort [Time Frame: Baseline, Week 24] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleSaxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Brief Summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is
more effective than placebo as a treatment for type 2 diabetic subjects who are not
sufficiently controlled with diet and exercise
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 added onto their blinded study medication. Subjects with screening
hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion
criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct
Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term
period were eligible to enter into the long-term treatment extension period.Saxagliptin dose
titration was not permitted.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])
Other Names:
BMS-477118Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
Other Names:
BMS-477118Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
Other Names:
BMS-477118Drug: Placebo matching Saxagliptin
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
Drug: Metformin
Tablets, Oral, 500 mg, daily (42 months LT)
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
Other Names:
BMS-477118Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Study Arm (s)
  • Experimental: Saxagliptin 2.5 mg (A)
    Metformin 500-2000 mg (as needed for rescue)
  • Experimental: Saxagliptin 5 mg (B)
    Metformin 500-2000 mg (as needed for rescue)
  • Experimental: Saxagliptin 10 mg (C)
    Metformin 500-2000 mg (as needed for rescue)
  • Placebo Comparator: Placebo (D)
    Metformin 500-2000 mg (as needed for rescue)
  • Experimental: Open-Label Treatment Cohort (Direct Enrollees) (E)
    Saxagliptin 10 mg
    Metformin 500-2000 mg (as needed for rescue)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment1035
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateAugust 2006
Eligibility Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus

- Drug naive

- Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)

- Fasting C-peptide >= 1 ng/mL

- Body mass index <= 40 kg/m2

Exclusion Criteria:

- Symptomatic poorly controlled diabetes

- Recent cardiac or cerebrovascular event

- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing
Potential
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Canada, Mexico, Puerto Rico, Taiwan

Administrative Information[ + expand ][ + ]

NCT Number NCT00121641
Other Study ID NumbersCV181-011
Has Data Monitoring CommitteeNot Provided
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2011

Locations[ + expand ][ + ]

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Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Jonesboro, Arizona, United States
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Mesa, Arizona, United States
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Pheonix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Castle Rock, Colorado, United States
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Denver, Colorado, United States
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Loveland, Colorado, United States
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Altamonte Springs, Florida, United States
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Chipley, Florida, United States
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Cocoa Beach, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Marianna, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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West Palm Beach, Florida, United States
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Vernon Hills, Illinois, United States
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Dubuque, Iowa, United States
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Iowa City, Iowa, United States
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Waterloo, Iowa, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Munfordville, Kentucky, United States
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New Orleans, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Chester, Maryland, United States
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Prince Frederick, Maryland, United States
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Ayer, Massachusetts, United States
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Boston, Massachusetts, United States
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Rolling Fork, Mississippi, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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St. Louis, Missouri, United States
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Kalispell, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Middletown, New Jersey, United States
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Toms River, New Jersey, United States
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Cooperstown, New York, United States
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Greensboro, North Carolina, United States
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Huntersville, North Carolina, United States
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Sparta, North Carolina, United States
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Statesville, North Carolina, United States
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Winston Salem, North Carolina, United States
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Athens, Ohio, United States
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Franklin, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Fleetwood, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Bristol, Tennessee, United States
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Morristown, Tennessee, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Texarkana, Texas, United States
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The Colony, Texas, United States
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Salt Lake City, Utah, United States
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Virginia Beach, Virginia, United States
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Olympia, Washington, United States
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Sydney, New South Wales, Australia
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Woollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Kippa Ring, Queensland, Australia
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Meadowbrook, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville South, South Australia, Australia
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Perth, Western Australia, Australia
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Quesnel, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Portage La Prairie, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Bathurst, New Brunswick, Canada
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Moncton, New Brunswick, Canada
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Manuels, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Newmarket, Ontario, Canada
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Oakville, Ontario, Canada
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Peterborough, Ontario, Canada
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Sarnia, Ontario, Canada
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Strathroy, Ontario, Canada
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Thornhill, Ontario, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Drummondville, Quebec, Canada
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Fleurimont, Quebec, Canada
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Gatineau, Quebec, Canada
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Granby, Quebec, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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St. Leonard, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Mexico City, Distrito Federal, Mexico
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Mexico D.F., Distrito Federal, Mexico
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo Leon, Mexico
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Hermosillo, Sonora, Mexico
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Aguascalientes, Mexico
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Durango, Mexico
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Carolina, Puerto Rico
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Guaynabo, Puerto Rico
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Ponce, Puerto Rico
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Rio Piedras, Puerto Rico
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San Juan, Puerto Rico
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Hualien, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan