Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

October 13, 2009

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To examine whether the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on metformin therapy alone [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00660907 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: Yes ]
To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Official Title ^ICMJE

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Adult Patients With Type 2 Diabetes

Brief Summary

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: dapagliflozin
Drug: glipizide
Drug: metformin hydrochloride

Study Arms / Comparison Groups

Experimental: dapagliflozin plus metformin
Active Comparator: glipizide plus metformin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

746

Estimated Completion Date

January 2011

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 Diabetes
Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
HbA1c >6.5% and </=10%

Exclusion Criteria:

Type 1 Diabetes
Insulin therapy within one year of enrolment
Renal (kidney) failure or dysfunction

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, France, Germany, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00660907

Responsible Party

Shamik Parikh, MDSr. Director, Medical Science, AstraZeneca

Study ID Numbers ^ICMJE

D1690C00004

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Bristol-Myers Squibb

Investigators ^ICMJE

Principal Investigator:

Michael A. Nauck, Prof. Dr. med.

Diabeteszentrum Bad Lauterberg, Germany

Information Provided By

AstraZeneca

Verification Date

October 2009

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