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Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
This study is currently recruiting participants.
Verified by AstraZeneca, December 2008
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

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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 16, 2009