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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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 (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Saxagliptin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline , Week 12 (LOCF) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup [ Time Frame: Baseline, Week 12 (LOCF) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Enrollment:	572
Study Start Date:	January 2008
Study Completion Date:	March 2010
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saxa Saxagliptin	Drug: Saxagliptin 2.5 mg once daily oral dose Other Name: Onglyza
No Intervention: Placebo Placebo to match	Drug: Placebo Placebo

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

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Peter Ohman, MD, PhD, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00614939 History of Changes
Other Study ID Numbers:	D1680C00007, EudraCT number 2007-004951-12
Study First Received:	January 31, 2008
Results First Received:	June 7, 2010
Last Updated:	May 16, 2011
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 of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:

DPP-4 inhibitors
HbA1c
incretins
Renal Impairment

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013