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Saxagliptin Triple Oral Therapy

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saxagliptin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Inadequate Glycaemic Control, Saxagliptin, Metformin, Sulfonylurea, Triple Oral Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saxagliptin 5 mg once daily

Placebo once daily

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
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]
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]
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]
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]
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)
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24

Full Information

First Posted
May 20, 2010
Last Updated
August 7, 2012
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01128153
Brief Title
Saxagliptin Triple Oral Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Inadequate Glycaemic Control, Saxagliptin, Metformin, Sulfonylurea, Triple Oral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saxagliptin 5 mg once daily
Arm Type
Experimental
Arm Title
Placebo once daily
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
5 mg tablet once daily for 24 weeks to be taken orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet once daily for 24 weeks to be taken orally
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Description
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Time Frame
From Baseline to Week 24 weeks
Secondary Outcome Measure Information:
Title
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Description
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time Frame
From Baseline to Week 24
Title
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Description
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time Frame
From Baseline to Week 24
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Description
Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Time Frame
From Baseline to Week 24
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Description
Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Time Frame
From Baseline to Week 24
Title
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Description
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
Time Frame
From Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayanti Visvanthan, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Simon Fisher, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vinod Mattoo, MD
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Moses, MBBS
Organizational Affiliation
Sydney Diabetes Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Broadmeadow
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Elizabeth Vale
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Camperdown
Country
Australia
Facility Name
Research Site
City
Herston
Country
Australia
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Sydney Mines
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Thornhill
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Kensington
State/Province
Prince Edward Island
Country
Canada
Facility Name
Research Site
City
Karnal
State/Province
Haryana
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Wonju
State/Province
Kangwon-do
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang
State/Province
Kyounggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Reading
State/Province
Berks
Country
United Kingdom
Facility Name
Research Site
City
ELY
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Research Site
City
Whitstable
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Westbury
State/Province
Wiltshire
Country
United Kingdom
Facility Name
Research Site
City
Ashford
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research Site
City
Chesterfield
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Peterborough
Country
United Kingdom
Facility Name
Research Site
City
Wellingborough
Country
United Kingdom

12. IPD Sharing Statement

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Saxagliptin Triple Oral Therapy

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