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Completed

NCT Number: NCT00885378

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Ludwigshafen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes
  • 18-78 years of age
  • Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
  • A1C: 7-10%
  • C-peptide: ≥ 0.8 ng/mL
  • Body mass index (BMI): ≤45 kg/m^2

Exclusion criteria

  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Fasting plasma glucose (FPG) >270 mg/dL
  • Significant cardiovascular history
  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Insulin therapy within one year of screening
  • Cardiovascular even within the prior 6 months
  • New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
  • Significant history of renal or hepatic disease
  • History of a psychiatric disorder, alcohol or drug abuse within the previous year
  • Treatment with potent CYP3A4 inhibitors or inducers
  • Immunocompromised participants
  • Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests

Treatment and study plan

Saxagliptin plus metformin IR

Drug

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

Other names: BMS-477118, Onglyza

Placebo plus metformin IR

Drug

Tablets, Oral, Placebo, Twice daily, 12 weeks

Primary outcomes

  1. Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12

    Time frame: Baseline, Week 12

    Mean change was adjusted for baseline.

Secondary outcomes

  1. Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)

    Time frame: Baseline, Week 12

    Mean change was adjusted for baseline.

  2. Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12

    Time frame: Week 12

    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

  3. Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12

    Time frame: Week 12

    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

Other outcomes

  1. Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary

    Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.

    AE = any new untoward medical occurrence/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. Treatment-related=Possible, Probable, or Certain relationship to drug.

  2. Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period

    Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.

    Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

  3. Participants With Confirmed Hypoglycemia

    Time frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.

    Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.

  4. Participant Electrocardiogram (ECG) Status at Baseline and Week 12

    Time frame: Baseline, Week 12

    Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.

  5. Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Baseline values reference the measurement for the cohort of participants evaluated at the given time point.

  6. Baseline and Mean Change From Baseline in Participant Heart Rate (HR)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Baseline values reference the measurement for the cohort of participants evaluated at the given time point.

  7. Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria

    Time frame: Baseline, Week 12

    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. ULN=upper limit of normal; LLN=lower limit of normal.

  8. Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria

    Time frame: Baseline, Week 12

    Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2009
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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