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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 December 2021 |
Main ID: |
EUCTR2007-005220-33-FR |
Date of registration:
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01/02/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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 Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone
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Scientific title:
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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 Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone |
Date of first enrolment:
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25/03/2008 |
Target sample size:
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746 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005220-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Provision of a written informed consent Diagnosed with type 2 diabetes Men or women equal or above 18 years WOCBP must be using an adequate method of contraception Treated with OAD therapy that includes metformin for at least 8 weeks prior to enrolment HbA1c above 6.5% and equal or below 10.0% FPG equal or below 270 mg/dL C-peptid level equal or above 1.0 ng/mL
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Type 1 diabetes, history of ketoacidosis or hyperosmolar non-ketonic coma, or corticosteroid-induced type 2 diabetes Symptoms of poorly controlled diabetes History of unstable or rapidly progressing renal disease Known condition of congenital renal glucosuria History of severe hepatobiliary disease or hepatotoxicity with any medication Pregnant or breasefeeding patients Insulin therapy within 1 year of enrolment Treatement with glucocorticoids within the last 30 days Congestive heart failure defined as NYHA class III or IV Significant cardiovascular history within the past 6 months Renal failure or renal dysfunction (Creatinine-clearance less than 60 ml/min) Urine albumin:creatinine ratio above 1,800 mg/g Severe hepatic insufficiency and/or significant abnormal liver function Serum total bilirubin above 2 mg/dL Creatinine kinase above 3 x ULN
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes MedDRA version: 9.1
Level: LLT
Classification code 10029505
Term: Non-insulin-dependent diabetes mellitus
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Intervention(s)
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Product Name: Dapagliflozin Product Code: BMS-512148 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dapagliflozin Current Sponsor code: BMS-512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Dapaglifozin Product Code: BMS-512148 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dapaglifozin Current Sponsor code: BMS-512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: Dapaglifozin Product Code: BMS-512148 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dapaglifozin Current Sponsor code: BMS-512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Glipizide BP 5 mg Product Name: Glipizide Pharmaceutical Form: Capsule, hard INN or Proposed INN: glipizide CAS Number: 29094-61-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Primary outcome variable - Change in HbA1c from baseline to week 52
Key secondary outcome variables - Absolute change in body weight from baseline to week 52 - Proportion of patients reporting at least one episode of hypoglycaemia over 52 weeks
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Secondary Objective: - To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin after 52 weeks of treatment - To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin after 52 weeks of treatment
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Main Objective: To examine whether, after 52 weeks of oral administration of double-blind treatment, the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non-inferior to glipizide (sulphonylurea) plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
Objectives after the 52-week extension period: - To assess the same safety and tolerability parameters as for the first 52 weeks, over 104 weeks treatment - To assess the maintenance of efficacy of dapagliflozin plus metformin over 104 weeks of treatment
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Secondary ID(s)
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2007-005220-33-GB
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D1690C00004
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 25/03/2008
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