Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00661362
First received: April 17, 2008
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.


Secondary Outcome Measures:
  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.

  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.

  • Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.

  • Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.

  • Proportion of Patients Achieving a Therapeutic Glycemic Response [ Time Frame: Baseline , Week 24 ] [ Designated as safety issue: No ]
    Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24


Enrollment: 570
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metformin + Saxagliptin
Drug: Saxagliptin
Oral tablet, once daily for 24 weeks
Other Name: Onglyza
Drug: Metformin
oral tablet, once daily for 24 weeks
Other Name: Glucophage
Placebo Comparator: 2
Metformin + Placebo
Drug: Placebo
oral tablet, once daily for 24 weeks
Drug: Metformin
oral tablet, once daily for 24 weeks
Other Name: Glucophage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Type 2 diabetes
  • Treatment with metformin at a stable dose >1500 mg/day
  • HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
  • Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661362

  Show 30 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Peter Ohman, MD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00661362     History of Changes
Other Study ID Numbers: D1680C00006
Study First Received: April 17, 2008
Results First Received: September 20, 2010
Last Updated: February 6, 2012
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
India: Drugs Controller General of India

Keywords provided by AstraZeneca:
DPP-4 inhibitors
HbA1c
Incretins

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014