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 Safety and Efficacy of Saxagliptin 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.

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

Registration Number: EUCTR2007-003998-55-DE

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2200

Inclusion Criteria

1. Provision of informed consent
2. Diagnosed with type 2 diabetes
3. Men or women above or equal to 18 years
4. 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 manner that the risk of pregnancy is minimized. Adequate
method of contraception is defined as a method of contraception with a failure
rate (Pearl Index) of < 1% (combined pills, tubal sterilization, IUD, 1 and 3
month injectable, subdermal implant, transdermal patch).
5. Treatment with metformin alone on a stable dose of 1500 mg or higher per day
for at least 8 weeks prior to visit 1
6. HbA1c higher than 6.5% and less than or equal to 10.0% at lead in visit
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

1. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma
2. Pregnant or breastfeeding patients
3. Insulin therapy within 1 year of enrolment
4. Previous treatment with any DPP-4 inhibitor
5. Treatment with thiazolidindione within 12 weeks prior to visit 1
6. Treatment with systemic glucocorticoids other than replacement therapy
7. Treatment with Cytochrome P450 3A4 inducers
8. Treatment with human immunodeficiency virus (HIV) treatment
9. Potential allergy to metformin, saxagliptin, glipizide, or placebo or excipients
10. Congestive heart failure
11. Significant cardiovascular history
12. History of haemoglobinopathies
13. History of alcohol abuse or illegal drug abuse within the past 12 months
14. Involvement in the planning and conduct of the study
15. Previous enrolment or randomization of treatment in the present study
16. Participation in a clinical study during the last 90 days prior to visit 1
17. Donation of blood, plasma or platelets within the past 3 months prior to visit 1
18. Any condition where, in the opinion of the investigator, participation in this study
may pose a significant risk to the patient (such as severe macro- or microvascular
complications), or could render the patient unable to successfully complete the
study.
19. Suspected or confimed poor protocol or medication compliance

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare that after 52-week oral administration of double-blind treatment, the absolute change from baseline in glycosylated haemoglobin A1c (HBA1c) level with saxagliptin plus metformin is non-inferior to glipizide (sulphonylurea) plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg or higher doses of metformin alone.;Secondary Objective: Three secondary objectives among all secondary objectives, are identified a priori for special attention to compare the effects of saxagliptin versus glipizide given as add-on therapy to metformin after a 52-week double-blind treatment period by evaluation of:<br>- Proportion of patients reporting at least one episode of hypoglycaemic event at week 52.<br>- Change from baseline in body weight at week 52.<br>- Durability of HbA1c effect based on week 24 over the 52 weeks as an efficacy objective;Primary end point(s): The primary outcome variable is the change from baseline in HbA1c at 52 weeks of treatment

Secondary Outcome Measures