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

Sponsor:	AstraZeneca
Collaborator:	Bristol-Myers Squibb
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660907

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: dapagliflozin Drug: glipizide Drug: metformin hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glipizide BMS 512148 Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin [ Time Frame: after 52 weeks treatment ] [ Designated as safety issue: No ]
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 ]
To show that a higher percentage of patients treated with dapagliflozin plus metformin reduce their baseline body weight with at least 5% compared to patients treated with glipizide plus metformin after 52 weeks of treatment. [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	816
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2013
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 dapagliflozin plus metformin	Drug: dapagliflozin Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks Drug: metformin hydrochloride Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks Other Name: Glucophage
Active Comparator: 2 glipizide plus metformin	Drug: glipizide Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks Other Name: Glucotrol Drug: metformin hydrochloride Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks Other Name: Glucophage

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660907

Show 77 Study Locations

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators

Principal Investigator:

Michael A. Nauck, Prof. Dr. med.

Diabeteszentrum Bad Lauterberg, Germany

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660907 History of Changes
Other Study ID Numbers:	D1690C00004
Study First Received:	April 15, 2008
Last Updated:	December 5, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Dapagliflozin
efficacy
safety
metformin
Type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Glipizide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012