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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392677
• Other study ID #: D1693C00005
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2011
• Last updated: February 11, 2014
• Start date: October 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSpain: Comité Ético de Investigación ClínicaSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: August 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• High HbA1c Level
• Inadequate Glycaemic Control
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
• placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Locations

Country	Name	City	State
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Etobicoke	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kensington	Prince Edward Island
Canada	Research Site	Laval	Quebec
Canada	Research Site	Markham	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Smiths Falls	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sydney Mines	Nova Scotia
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	Beroun
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Jilove U Prahy
Czech Republic	Research Site	Praha
Czech Republic	Research Site	Praha 5
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Semily
Czech Republic	Research Site	Vyskov
Germany	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
Poland	Research Site	Kielce
Poland	Research Site	Lodz
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Zgierz
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Kosice
Slovakia	Research Site	Povazska Bystrica
Slovakia	Research Site	Rimavska Sobota
Spain	Research Site	A Coruna	Galicia
Spain	Research Site	A Coruña
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona	Cataluna
Spain	Research Site	Oviedo
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Sta Coloma de Gramanet (bcn)	Catalu?a
Spain	Research Site	Sta Coloma de Gramenet (BCN)

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

Canada,  Czech Republic,  Germany,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change From Baseline in HbA1c Levels	To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.	Baseline to week 24	No
Secondary	Adjusted Mean Change From Baseline in FPG	To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo	Baseline to week 24	No
Secondary	Adjusted Mean Change From Baseline in Total Body Weight	To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo	Baseline to week 24	No
Secondary	Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)	To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo	Baseline to week 24	No
Secondary	Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure	To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo	Baseline to week 8	No

External Links

•   D1693C00005.pdf