Saxagliptin Triple Oral Therapy

August 7, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia
        • Research Site
      • Herston, Australia
        • Research Site
    • New South Wales
      • Broadmeadow, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • South Australia
      • Daw Park, South Australia, Australia
        • Research Site
      • Elizabeth Vale, South Australia, Australia
        • Research Site
    • Victoria
      • Melbourne, Victoria, Australia
        • Research Site
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Sydney Mines, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Thornhill, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Kensington, Prince Edward Island, Canada
        • Research Site
  • India
    • Haryana
      • Karnal, Haryana, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Research Site
    • Maharashtra
      • Pune, Maharashtra, India
        • Research Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
    • Kangwon-do
      • Wonju, Kangwon-do, Korea, Republic of
        • Research Site
    • Kyounggi-do
      • Goyang, Kyounggi-do, Korea, Republic of
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
  • United Kingdom
      • Ashford, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Chesterfield, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Peterborough, United Kingdom
        • Research Site
      • Wellingborough, United Kingdom
        • Research Site
    • Berks
      • Reading, Berks, United Kingdom
        • Research Site
    • Cambridgeshire
      • ELY, Cambridgeshire, United Kingdom
        • Research Site
    • Kent
      • Whitstable, Kent, United Kingdom
        • Research Site
    • Wiltshire
      • Westbury, Wiltshire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo once daily
Drug: Placebo
tablet once daily for 24 weeks to be taken orally
Experimental: Saxagliptin 5 mg once daily
Drug: Saxagliptin
5 mg tablet once daily for 24 weeks to be taken orally
Other Names:
  • Onglyza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Time Frame: From Baseline to Week 24 weeks
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
From Baseline to Week 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
From Baseline to Week 24
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
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
From Baseline to Week 24
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
Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
From Baseline to Week 24
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
Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
From Baseline to Week 24
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
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
From Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 20, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1680L00006
  • CV181-117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Saxagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe