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:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00121641
First received: July 15, 2005
Last updated: June 4, 2014
Last verified: June 2014
  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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Saxagliptin
Drug: Placebo matching Saxagliptin
Drug: Metformin
Drug: Placebo matching Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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%.


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 ]

Other Outcome Measures:
  • Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

  • Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

  • Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

  • Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.

  • Overall Summary of Adverse Events During ST+LT Treatment Period [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.

  • Marked Laboratory Abnormalities - During ST + LT Treatment Period [ Time Frame: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. ] [ Designated as safety issue: Yes ]
    A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.

  • Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Hematocrit During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period [ Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline in Systolic Blood Pressure During the ST + LT Period [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline in Heart Rate During the ST + LT Period [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period [ Time Frame: Baseline, Weeks 12, 24, 76, 102, 154, 206 ] [ Designated as safety issue: Yes ]
    The normality/abnormality of the ECG tracing was determined by the investigator.

  • Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. ] [ Designated as safety issue: Yes ]
    AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.

  • Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort [ Time Frame: Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks. ] [ Designated as safety issue: Yes ]
    A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.

  • All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. ] [ Designated as safety issue: Yes ]
    Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

  • Confirmed Hypoglycemia During ST + LT Treatment Period [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm. ] [ Designated as safety issue: Yes ]
    'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms

  • All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. ] [ Designated as safety issue: Yes ]
    Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

  • Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort [ Time Frame: AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks. ] [ Designated as safety issue: Yes ]
    'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms

  • Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort [ Time Frame: Baseline, Weeks 12, 24, 76, 102, 154, 206 ] [ Designated as safety issue: Yes ]
    The normality/abnormality of the ECG tracing was determined by the investigator.

  • Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 ] [ Designated as safety issue: Yes ]
  • Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort [ Time Frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167 ] [ Designated as safety issue: Yes ]

Enrollment: 1035
Study Start Date: July 2005
Study Completion Date: February 2010
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Experimental: Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Experimental: Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Placebo Comparator: Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
Drug: 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: Metformin
Tablets, Oral, 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)

Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
Other Name: BMS-477118
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00121641

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Sponsors and Collaborators
AstraZeneca
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00121641     History of Changes
Other Study ID Numbers: CV181-011
Study First Received: July 15, 2005
Results First Received: April 12, 2011
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

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