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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614939
• Other study ID #: D1680C00007
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2008
• Last updated: May 16, 2011
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of HealthCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: March 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
2.5 mg once daily oral dose
• Placebo
Placebo

Locations

Country	Name	City	State
Belarus	Research Site	Brest
Belarus	Research Site	Gomel
Belarus	Research Site	Minsk
Bulgaria	Research Site	Dimitrovgrad
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Veliko Tarnovo
Croatia	Research Site	Karlovac
Croatia	Research Site	Osijek
Croatia	Research Site	Rijeka
Croatia	Research Site	Split
Croatia	Research Site	Zagreb
Czech Republic	Research Site	Moravsky Krumlov
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Teplice
Czech Republic	Research Site	Usti Nad Labem
Czech Republic	Research Site	Znojmo
Estonia	Research Site	Tallinn
Germany	Research Site	Dieburg
Germany	Research Site	Dusseldorf
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Mannheim
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
Hungary	Research Site	Kalocsa
Hungary	Research Site	Kecskemet
Hungary	Research Site	Zalaegerszeg
Latvia	Research Site	Riga
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Panevezys
Lithuania	Research Site	Vilnius
Poland	Research Site	Bialystok
Poland	Research Site	Ciechanow
Poland	Research Site	Golub Dobrzyn
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Lodz	90-153
Poland	Research Site	Makow Mazowiecki
Poland	Research Site	Radom
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Romania	Research Site	Bacau
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Bucuresti
Romania	Research Site	Satu-mare	Satu Mare
Romania	Research Site	Sf Gheorghe
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	St.petersburg
Russian Federation	Research Site	Yaroslavl
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Ivano-frankivsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Mykolayiv
Ukraine	Research Site	Sumy
Ukraine	Research Site	Ternopil
Ukraine	Research Site	Zaporizhzhya
United States	Research Site	Baltimore	Maryland
United States	Research Site	Charleston	West Virginia
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Concord	California
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Great Falls	Montana
United States	Research Site	Greenville	North Carolina
United States	Research Site	Morehead City	North Carolina
United States	Research Site	Sacramento	California
United States	Research Site	Topeka	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belarus,  Bulgaria,  Croatia,  Czech Republic,  Estonia,  Germany,  Hungary,  Latvia,  Lithuania,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (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.	Baseline , Week 12 (LOCF)	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup	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.	Baseline, Week 12 (LOCF)	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup	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.	Baseline, Week 12 (LOCF)	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup	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.	Baseline, Week 12 (LOCF)	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup	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.	Baseline, Week 12 (LOCF)	No
Secondary	Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to 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.	Baseline , Week 52	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup	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.	Baseline, Week 52	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup	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.	Baseline, Week 52	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup	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.	Baseline, Week 52	No
Secondary	Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup	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	Baseline, Week 52	No