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Saxagliptin Triple Oral Therapy

NCT ID: NCT01128153

Last Updated: 2012-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Type 2 Diabetes

Keywords

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Type 2 Diabetes Inadequate Glycaemic Control Saxagliptin Metformin Sulfonylurea Triple Oral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saxagliptin 5 mg once daily

Group Type EXPERIMENTAL

Saxagliptin

Intervention Type DRUG

5 mg tablet once daily for 24 weeks to be taken orally

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet once daily for 24 weeks to be taken orally

Interventions

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Saxagliptin

5 mg tablet once daily for 24 weeks to be taken orally

Intervention Type DRUG

Placebo

tablet once daily for 24 weeks to be taken orally

Intervention Type DRUG

Other Intervention Names

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Onglyza

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayanti Visvanthan, MD

Role: STUDY_CHAIR

AstraZeneca

Simon Fisher, MD

Role: STUDY_CHAIR

AstraZeneca

Vinod Mattoo, MD

Role: STUDY_CHAIR

Bristol-Myers Squibb

Robert Moses, MBBS

Role: PRINCIPAL_INVESTIGATOR

Sydney Diabetes Centre

Locations

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Research Site

Broadmeadow, New South Wales, Australia

Site Status

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Wollongong, New South Wales, Australia

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Daw Park, South Australia, Australia

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Elizabeth Vale, South Australia, Australia

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Melbourne, Victoria, Australia

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Camperdown, , Australia

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Herston, , Australia

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St. John's, Newfoundland and Labrador, Canada

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Sydney Mines, Nova Scotia, Canada

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Thornhill, Ontario, Canada

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Kensington, Prince Edward Island, Canada

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Karnāl, Haryana, India

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Bangalore, Karnataka, India

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Indore, Madhya Pradesh, India

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Pune, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Wŏnju, Gangwon-do, South Korea

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Goyang, Kyounggi-do, South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Bangkok, , Thailand

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Reading, Berks, United Kingdom

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Ely, Cambridgeshire, United Kingdom

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Whitstable, Kent, United Kingdom

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Westbury, Wiltshire, United Kingdom

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Ashford, , United Kingdom

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Belfast, , United Kingdom

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Blackpool, , United Kingdom

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Chesterfield, , United Kingdom

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Coventry, , United Kingdom

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Glasgow, , United Kingdom

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Peterborough, , United Kingdom

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Wellingborough, , United Kingdom

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Countries

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Australia Canada India South Korea Thailand United Kingdom

Other Identifiers

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CV181-117

Identifier Type: -

Identifier Source: secondary_id

D1680L00006

Identifier Type: -

Identifier Source: org_study_id