Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

This study is ongoing, but not recruiting participants.

First Received: June 16, 2008 Last Updated: April 6, 2009 History of Changes

Sponsors and Collaborators:	AstraZeneca Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00698932

Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Saxagliptin Drug: Placebo	Phase III

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness

Drug Information available for: Saxagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week International, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) after 24 weeks oral administration [ Time Frame: Multiple time points during 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the effects of Saxagliptin versus placebo after 24 weeks double-blind treatment [ Time Frame: Multiple times points during 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	530
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Saxagliptin oral tablet, once daily for 24 weeks
2: Placebo Comparator	Drug: Placebo oral tablet, once daily for 24 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with Type 2 diabetes
Patients should be drug naïve ie, not received medical treatment for diabetes,
HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698932

Show 30 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Director:	Peter Öhman, MD, PhD	AstraZeneca, Wilmington, USA
Study Chair:	Deborah Price, MSc	AstraZeneca, Wilmington, USA

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Peter Öhman, MD, PhD, Medical Science Director )
Study ID Numbers:	D1680C00005
Study First Received:	June 16, 2008
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00698932 History of Changes
Health Authority:	China: State Food and Drug Administration; India: Drugs Controller General of India; Philippines: Bureau of Food and Drugs; South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:

DPP-4 inhibitors
HBA1c
Incretins

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Incretins
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009