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Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus; High HbA1c Level; Inadequate Glycaemic Control

Intervention: dapagliflozin (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Eva Johnsson, PhD, Medical Science Director, Study Director, Affiliation: AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Stephan Matthaei, Prof.Dr.med, Principal Investigator, Affiliation: Diabetes-Zentrum Quakenbruck

Summary

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Clinical Details

Official title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

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

Primary outcome: Adjusted Mean Change From Baseline in HbA1c Levels

Secondary outcome:

Adjusted Mean Change From Baseline in FPG

Adjusted Mean Change From Baseline in Total Body Weight

Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes mellitus

- Men or women age ≥ 18 years old

- Stable dose combination of metformin and sulfonylurea

- HbA1c ≥7. 7% and ≤11. 0%

Exclusion Criteria:

- Type 1 diabetes mellitus or diabetes insipidus

- Recent cardiovascular events

- Kidney or urological disorders

- Hepatic disorders

Locations and Contacts

Research Site, Quebec, Canada

Research Site, Beroun, Czech Republic

Research Site, Ceske Budejovice, Czech Republic

Research Site, Jilove U Prahy, Czech Republic

Research Site, Praha 5, Czech Republic

Research Site, Praha 6, Czech Republic

Research Site, Praha, Czech Republic

Research Site, Semily, Czech Republic

Research Site, Vyskov, Czech Republic

Research Site, Asslar, Germany

Research Site, Aßlar, Germany

Research Site, Berlin, Germany

Research Site, Dresden, Germany

Research Site, Falkensee, Germany

Research Site, Neuwied, Germany

Research Site, Pirna, Germany

Research Site, Kielce, Poland

Research Site, Lodz, Poland

Research Site, Lublin, Poland

Research Site, Poznan, Poland

Research Site, Poznań, Poland

Research Site, Warszawa, Poland

Research Site, Zgierz, Poland

Research Site, Łódź, Poland

Research Site, Banska Bystrica, Slovakia

Research Site, Kosice, Slovakia

Research Site, Povazska Bystrica, Slovakia

Research Site, Rimavska Sobota, Slovakia

Research Site, A Coruña, Spain

Research Site, Barcelona, Spain

Research Site, Oviedo, Spain

Research Site, Sta Coloma de Gramenet (BCN), Spain

Research Site, Edmonton, Alberta, Canada

Research Site, Oviedo, Asturias, Spain

Research Site, Sta Coloma de Gramanet (bcn), Catalu?a, Spain

Research Site, Barcelona, Cataluna, Spain

Research Site, A Coruna, Galicia, Spain

Research Site, Winnipeg, Manitoba, Canada

Research Site, St. John's, Newfoundland and Labrador, Canada

Research Site, Halifax, Nova Scotia, Canada

Research Site, Sydney Mines, Nova Scotia, Canada

Research Site, Brampton, Ontario, Canada

Research Site, Etobicoke, Ontario, Canada

Research Site, Markham, Ontario, Canada

Research Site, Smiths Falls, Ontario, Canada

Research Site, Kensington, Prince Edward Island, Canada

Research Site, Laval, Quebec, Canada

Additional Information

D1693C00005.pdf

Starting date: October 2011
Last updated: February 11, 2014

Page last updated: August 23, 2015

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