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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660907
First received: April 15, 2008
Last updated: September 24, 2013
Last verified: September 2013
  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 3

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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Change in Body Weight [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.

  • Proportion of Participants With at Least One Episode of Hypoglycemia [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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.

  • Proportion of Participants With Body Weight Reduction of at Least 5% [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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.


Enrollment: 814
Study Start Date: March 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Argentina
Research Site
Caba, BA, Argentina
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La Plata, Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Ciudad Autonoma de Bs. As., Argentina
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Ciudad de Buenos Aires, Argentina
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Cordoba, Argentina
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Corrientes, Argentina
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Santa Fe, Argentina
France
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L'Aigle, France
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Murs Erigne, France
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Nantes, France
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Paris, France
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Tours, France
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Vannes, France
Germany
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Bad Lauterberg, Germany
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heilbronn, Germany
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Ludwigshafen, Germany
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Mainz, Germany
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Munchen, Germany
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Pirna, Germany
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Ratzeburg, Germany
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Schmiedeberg, Germany
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Stuttgart, Germany
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Wangen, Germany
Italy
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Bari, BA, Italy
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Milano, MI, Italy
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Padova, PD, Italy
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Perugia, PG, Italy
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Pisa, PI, Italy
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Firenze, Italy
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Roma, Italy
Mexico
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Mexico, D.f., Mexico
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Acapulco, Guerrero, Mexico
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Guadalajara, Jalisco, Mexico
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Veracruz, Mexico
Netherlands
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Den Haag, Netherlands
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Deurne, Netherlands
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Gorinchem, Netherlands
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Groningen, Netherlands
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Lichtenvoorde (gld), Netherlands
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Losser, Netherlands
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Poortvliet, Netherlands
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Rotterdam, Netherlands
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Wildervank, Netherlands
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Zutphen, Netherlands
South Africa
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Witbank, Gauteng, South Africa
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Durban, Kwazulu Natal, South Africa
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Parow, W Cape, South Africa
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Cape Town, Western Cape, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Umkomaas, South Africa
Spain
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Barcelona, Cataluna, Spain
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Cornella de Llobregat (bcn), Cataluna, Spain
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Madrid, Comunidad de Madrid, Spain
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Alicante, Comunidad Valenciana, Spain
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Alzira (valencia), Comunidad Valenciana, Spain
Sweden
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Angelholm, Sweden
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Goteborg, Sweden
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Jarfalla, Sweden
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Lund, Sweden
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Malmo, Sweden
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Skene, Sweden
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Sodertalje, Sweden
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Stockholm, Sweden
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Umea, Sweden
United Kingdom
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Reading, Berks, United Kingdom
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Aylesbury, Bucks, United Kingdom
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Cookstown, N. Ireland, United Kingdom
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Ecclesfield, Sheffield, United Kingdom
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Addlestone, Surrey, United Kingdom
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Trowbridge, Wiltshire, United Kingdom
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Bath, United Kingdom
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Bolton, United Kingdom
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Bury St Edmonds, United Kingdom
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Coventry, United Kingdom
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Edinburgh, United Kingdom
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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660907     History of Changes
Other Study ID Numbers: D1690C00004
Study First Received: April 15, 2008
Results First Received: January 21, 2013
Last Updated: September 24, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 August 21, 2014