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.

Phase 1

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

• Registration Number: EUCTR2007-003998-55-SK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-09
• Last Update Posted: 13 March 2017

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 must be using an adequate method of contraception
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. Individuals who could render the patient unable to 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