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Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614939
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : July 7, 2010
Last Update Posted : May 19, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 13, 2008
Results First Submitted Date  ICMJE June 7, 2010
Results First Posted Date  ICMJE July 7, 2010
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline , Week 12 (LOCF) ]
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Absolute change from baseline in glucosylated haemoglobin A1c (HbA1c) [ Time Frame: Assessed after 12 and 52 weeks treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup [ Time Frame: Baseline, Week 12 (LOCF) ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup [ Time Frame: Baseline, Week 12 (LOCF) ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup [ Time Frame: Baseline, Week 12 (LOCF) ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup [ Time Frame: Baseline, Week 12 (LOCF) ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.
  • Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 [ Time Frame: Baseline , Week 52 ]
    Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup [ Time Frame: Baseline, Week 52 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup [ Time Frame: Baseline, Week 52 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup [ Time Frame: Baseline, Week 52 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
  • Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup [ Time Frame: Baseline, Week 52 ]
    Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • Safety and tolerability [ Time Frame: Assessed after 12 and 52 weeks treatment ]
  • Other secondary measurements of glucose metabolism [ Time Frame: Assessed after 12 and 52 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Official Title  ICMJE 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 (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Saxagliptin
    2.5 mg once daily oral dose
    Other Name: Onglyza
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Saxa
    Saxagliptin
    Intervention: Drug: Saxagliptin
  • No Intervention: Placebo
    Placebo to match
    Intervention: Drug: Placebo
Publications * Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2010)
572
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2008)
168
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Bulgaria,   Croatia,   Czech Republic,   Estonia,   Germany,   Hungary,   Latvia,   Lithuania,   Poland,   Romania,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00614939
Other Study ID Numbers  ICMJE D1680C00007
EudraCT number 2007-004951-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Ohman, MD, PhD, Medical Science Director, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Peter Ohman, MD, PhD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
PRS Account AstraZeneca
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP