An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone
- Conditions
- on-insulin dependent type 2 diabetesMedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus
- Registration Number
- EUCTR2007-006095-11-FR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 710
Provision of informed consent
Diagnosed with type 2 diabetes
Man or women equal to or above 18 years of age
Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks
Women of childbearing potential must be using an adequate method of contraception.
HbA1c above 6.5% and below or equal to 10.0%
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
Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
Pregnant of breastfeeding patients
Insulin therapy within 1 year
Previous treatment with any DPP-4 inhibitor
Treatment with thiazolidinedione within 12 weeks
Treatment with systemic glucocorticoids other than replacement therapy, CYP460 3A4 inducers and/or HIV treatment/antiviral drugs
Potential allergy to metformin, saxagliptin, sitagliptin, or placebo
Contraindications to therapy as outlined in the saxagliptin IB, metformin package insert or sitagliptin package insert
Congestive heart failure defined as NYHA class III or IV and/or left ventricular ejection fraction equal to or below 40%
Significant cardiovascular history within the 6 past months
History of haemoglobinopathies, alcohol abuse or illegal drug abuse
Involvement in the planning and conduct of the study
Previous enrolment or randomization of treatment in the present study
Participation in a clinical study during the last 90 days
Donation of blood, plasma or platelets within the past 3 months
Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study
Suspected or confirmed poor protocol or medication compliance as judged by the investigator
Serum creatinine equal to or above 133 micromol/L, for men and 124 micromol/L for women
Active liver disease and/or significant abnormal liver function
Creatinine kinase equal or above 3xULN
History of positive serologic evidence of current infectious liver disease
Any clinically significant abnormality identified on physical examination or laboratory tests or ECG, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method