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

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus

• Registration Number: EUCTR2007-005220-33-NL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-01
• Study Completion: 2013-01-16
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 746

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 breastfeeding 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified