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Register:	EUCTR
Last refreshed on:	2 December 2013
Main ID:	EUCTR2007-005220-33-SE
Date of registration:	27/12/2007
Prospective Registration:	Yes
Primary sponsor:	AstraZeneca AB
Public 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
Scientific 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
Date of first enrolment:	14/02/2008
Target sample size:	746
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005220-33
Study type:	Interventional clinical trial of medicinal product
Study design:	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
Phase:

Countries of recruitment
France	Germany	Italy	Netherlands	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes
MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus

Intervention(s)

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

Primary Outcome(s)

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
- 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.

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
- Proportion of patients with body weight decrease = 5% from baseline to week 52

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

Secondary Outcome(s)

Secondary ID(s)

D1690C00004

2007-005220-33-GB

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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