A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-on Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin - Prompt
- Conditions
- on-insulin dependent type 2 diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus
- Registration Number
- EUCTR2009-012775-10-FR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 268
1. Provision of informed consent.
2. Men or women who are =18 years of age at time of consenting upon Visit 1.
3. Clinical diagnosis of type 2 diabetes.
4. Treatment with metformin alone (any formulation) on stable doses of 1500 to 1700 mg per day for at least 8 weeks prior to Visit 1.
5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
- WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea =12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35 mIU/mL).
- Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (eg, vasectomy), should be considered to be of childbearing potential.
6. HbA1c =7.0% and =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
1. Any clinically significant abnormality identified on physical examination or
laboratory tests that would compromise patient’s safety or successful
participation in the study as judged by the investigator.
2. Patients who have previously been intolerant to or non-compliant with a total
daily dose of metformin higher than 1500 to 1700 mg.
3. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic
coma.
4. Pregnant or breastfeeding patients.
5. Prior use of insulin or injectable GLP-1 analogue (exenatide or liraglutide) within 3
months of the study start.
6. Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,
local injected and topical use of glucocorticoids are allowed.
7. Treatment with cytochrome P450 3A4 (CYP450 3A4) inducers, eg, carbamazepine,
dexamethasone, phenobarbital, phenytoin, rifampin and St. John’s Worth.
8. Potential allergy to saxagliptin, placebo or formulation excipients.
9. Past hypersensitivity reaction to a DPP-4 inhibitor.
10. Contraindications to therapy as outlined in the saxagliptin Investigator’s
Brochure.
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