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Saxagliptin Triple Oral Therapy

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01128153
First received: May 20, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Saxagliptin
Drug: Placebo
 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, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) [ Time Frame: From Baseline to Week 24 weeks ] [ Designated as safety issue: No ]
    Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model


Secondary Outcome Measures:
  • Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

  • Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model

  • Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
    Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24


Enrollment: 257
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin 5 mg once daily Drug: Saxagliptin
5 mg tablet once daily for 24 weeks to be taken orally
Other Name: Onglyza
Placebo Comparator: Placebo once daily Drug: Placebo
tablet once daily for 24 weeks to be taken orally

Detailed Description:

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

  Eligibility

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

Inclusion Criteria:

  • Written Informed Consent
  • Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
  • BMI < or = 40 kg/m2

Exclusion Criteria:

  • Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
  • History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
  • Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
  • Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
  • Estimated CrCl < 60 ml/min at Visit 2
  • CHF (NYHA class III or IV) and/or LVEF <40%
  • Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
  • Creatine kinase > or = 10 x ULN at Visit 2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128153

  Show 33 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Chair: Jayanti Visvanthan, MD AstraZeneca
Study Chair: Simon Fisher, MD AstraZeneca
Study Chair: Vinod Mattoo, MD Bristol-Myers Squibb
Principal Investigator: Robert Moses, MBBS Sydney Diabetes Centre
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01128153     History of Changes
Other Study ID Numbers: D1680L00006, CV181-117
Study First Received: May 20, 2010
Results First Received: June 11, 2012
Last Updated: August 7, 2012
Health Authority: Australia: Therapeutic Goods Administration
Australia: Human Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Drugs Controller General of India
India: Institutional Review Board
Korea: Food and Drug Administration
Thailand: Ethical Committee
Thailand: Ministry of Public Health

Keywords provided by AstraZeneca:
Type 2 Diabetes
Inadequate Glycaemic Control
Saxagliptin
 Metformin
Sulfonylurea
Triple Oral Therapy

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

ClinicalTrials.gov processed this record on May 19, 2013