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
  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:


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
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: 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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 18, 2014