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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660907
• Other study ID #: D1690C00004
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2008
• Last updated: March 10, 2015
• Start date: March 2008
• Est. completion date: January 2013

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyMexico: Federal Commission for Protection Against Health RisksNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)South Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1217
• Est. completion date: January 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
• Type 2 Diabetes

Intervention

Drug:
• dapagliflozin
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
• glipizide
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
• metformin hydrochloride
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Capital Federal
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Corrientes
Argentina	Research Site	La Plata
Argentina	Research Site	Rosario
Argentina	Research Site	Santa Fe
France	Research Site	L'aigle
France	Research Site	Murs Erigne
France	Research Site	Nantes
France	Research Site	Nantes Cedex 1
France	Research Site	Paris
France	Research Site	Tours
France	Research Site	Vannes
Germany	Research Site	Bad Lauterberg
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Hamburg
Germany	Research Site	Heilbronn
Germany	Research Site	Ludwigshafen
Germany	Research Site	Mainz
Germany	Research Site	Pirna
Germany	Research Site	Schmiedeberg
Germany	Research Site	Wangen
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Roma
Mexico	Research Site	Acapulco
Mexico	Research Site	Guadalajara
Mexico	Research Site	México
Mexico	Research Site	Veracruz
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deurne
Netherlands	Research Site	Gorinchem
Netherlands	Research Site	Groningen
Netherlands	Research Site	Lichtenvoorde (gld)
Netherlands	Research Site	Losser
Netherlands	Research Site	Poortvliet
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Wildervank
Netherlands	Research Site	Zutphen
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Parow
South Africa	Research Site	Pretoria
South Africa	Research Site	Umkomaas
South Africa	Research Site	Witbank
Spain	Research Site	Alicante
Spain	Research Site	Alzira (Valencia)
Spain	Research Site	Barcelona
Spain	Research Site	Cornellá de Llobregat (BCN)
Spain	Research Site	Madrid
Spain	Research Site	Sevilla
Sweden	Research Site	Göteborg
Sweden	Research Site	Järfälla
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Skene
Sweden	Research Site	Södertälje
Sweden	Research Site	Stockholm
Sweden	Research Site	Umeå
United Kingdom	Research Site	Addlestone
United Kingdom	Research Site	Aylesbury
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Bury St Edmonds
United Kingdom	Research Site	Cookstown
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Ecclesfield
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Mortimer Reading
United Kingdom	Research Site	Trowbridge

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

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

References & Publications (1)

Nauck MA, Del Prato S, Meier JJ, Durán-García S, Rohwedder K, Elze M, Parikh SJ. Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, ac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c Levels	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.	Baseline to Week 52	No
Secondary	Adjusted Mean Change in Body Weight	To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.	Baseline to Week 52	No
Secondary	Proportion of Participants With at Least One Episode of Hypoglycemia	To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.	Baseline to Week 52	Yes
Secondary	Proportion of Participants With Body Weight Reduction of at Least 5%	To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.	Baseline to Week 52	No

External Links

•   CSR-D1690C00004.pdf