Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	AstraZeneca Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00661362

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 who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Saxagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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 Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy

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 given as add on therapy to metformin during 24 weeks. [ Time Frame: Multiple time points during 24 weeks ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental Metformin + Saxagliptin	Drug: Saxagliptin Oral tablet, one daily for 24 weeks Drug: Metformin oral tablet, once daily for 24 weeks
2: Placebo Comparator Metformin + Placebo	Drug: Placebo oral tablet, once daily for 24 weeks Drug: Metformin 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
Treatment with metformin at a stable dose >1500 mg/day
HbA1c ≥ 7.0% and ≤10.0%

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: NCT00661362

Contacts

Contact: Peter Ohman

+1 302 885 1482

peter.ohman@astrazeneca.com

Locations

China
Research Site	Recruiting
BEIJING, China
Research Site	Recruiting
CHONGQING, China
Research Site	Not yet recruiting
TIANJIN, China
Research Site	Recruiting
SHANGHAI, China
China, ANHUI
Research Site	Recruiting
HEFEI, ANHUI, China
China, GUANGDONG
Research Site	Recruiting
GUANGZHOU, GUANGDONG, China
China, HU BEI
Research Site	Recruiting
WUHAN, HU BEI, China
China, HUNAN
Research Site	Not yet recruiting
CHANGSHA, HUNAN, China
China, JIANGSU
Research Site	Recruiting
NANJING, JIANGSU, China
China, LIAONING
Research Site	Recruiting
SHENYANG, LIAONING, China
China, SI CHUAN
Research Site	Recruiting
CHENGDU, SI CHUAN, China
India, Andhra Pradesh
Research Site	Not yet recruiting
HYDERABAD, Andhra Pradesh, India
India, KARNATAKA
Research Site	Recruiting
BANGALORE, KARNATAKA, India
Research Site	Recruiting
MANGALORE, KARNATAKA, India
India, MAHARASHTRA
Research Site	Not yet recruiting
NAGPUR, MAHARASHTRA, India
Korea, Republic of
Research Site	Recruiting
BUCHEON, Korea, Republic of
Research Site	Recruiting
SEOUL, Korea, Republic of
Research Site	Recruiting
GOYANG, Korea, Republic of
Research Site	Not yet recruiting
GWANGJU, Korea, Republic of
Research Site	Recruiting
PUSAN, Korea, Republic of
Research Site	Recruiting
DAEGU, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Study Director:	Peter Ohman, MD	AstraZeneca
Study Chair:	Deborah Price, MSc	AstraZeneca

More Information

Study ID Numbers:	D1680C00006
Study First Received:	April 17, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00661362
Health Authority:	China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA); India: Drugs Controller General of India

Keywords provided by AstraZeneca:

DPP-4 inhibitors
HbA1c
Incretins

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009