Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment - Full Text View

Sponsors and Collaborators:	AstraZeneca Bristol-Myers Squibb
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00614939

Purpose

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Saxagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Short-Term 12-Week, Multi-Centre, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment With an Additional 40-Week Long-Term Observational Period

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Absolute change from baseline in glucosylated haemoglobin A1c (HbA1c) [ Time Frame: Assessed after 12 and 52 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: Assessed after 12 and 52 weeks treatment ] [ Designated as safety issue: No ]
Other secondary measurements of glucose metabolism [ Time Frame: Assessed after 12 and 52 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	168
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Placebo	Drug: Placebo Placebo
2: Experimental Saxagliptin	Drug: Saxagliptin 2.5 mg once daily oral dose

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
Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
HbA1c ≥7.0% and ≤11.0%

Exclusion Criteria:

Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614939

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Show 75 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

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

More Information

Responsible Party:	AstraZeneca ( Peter Ohman, MD, PhD, Medical Science Director )
Study ID Numbers:	D1680C00007, EudraCT number 2007-004951-12
Study First Received:	January 31, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00614939
Health Authority:	Belarus: Ministry of Health; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:

DPP-4 inhibitors
HbA1c
incretins
Renal Impairment

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009