A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) with an additional 40-week, Randomized, Parallel-group, Double-blind, Placebo-controlled Long-term Observational Period

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

Registration Number: EUCTR2007-004951-12-EE

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

At visit 1:
Provision of informed consent
Diagnosed with type 2 diabetes
Men or women who are equal to or above 18 years of age
Documented history of CrCl less than 50 ml/min within 3 last months
WOCBP using an adequate method of contraception
Men should take precaution not to father a baby while participating in the study and 4 weeks after
At visit 2:
HbA1c above or equal to 7.0% and less than or equal to 11.0%
C-peptide level above or equal to 0.375nmol/L, 1.0ng/mL
Estimated CrCl less than 50 ml/min
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

At visit 1:
Pregnancy or breastfeeding
Initiation of insulin therapy within 4 weeks of study entry or unstable insulin therapy within 4 weeks of study entry
Allowed oral antidiabetic therapy that has not been stable within the last 4 weeks
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic
Treatment with metformin within 4 weeks prior to visit 1
Thiazolidinedione tratment has not been stable within 12 weeks of study entry
Systemic treatment with oral prednisolone above 10 mg per day or comparable dose of systemic glucocorticoid
Treatment with CYP450 3A4 inducers, HIV or antiviral drugs
Contraindications to therapy as outlined in the saxagliptin IB
Congestive heart failure (NYHA) class III or IV and/or left ventricular ejection fraction equal to or less than 40%
Significant cardiovascular history within the past 6 months
Type I diabetes, history of diabetic ketoacidosis or hypomolar non-ketonic coma
History of 2 or more major hypoglycemic events the last 3 months, haemoglobinopathies, alcohol or illegal drug abuse
Donation of blood, plasma or platelets within the last 3 months
Involvement in planning or conduct of the study
Participating in a clinical study within 90 days
Unable to complete the study, protocol or medication non-compliant
At visit 2:
Active liver disease and/or significant abnormal liver function
Creatinine kinase above or equal to 3xULN
Anemia
Clinically significant abnormality
Patients receiving peritoneal dialysis, and patients who are expected to initiate peritoneal dialysis whithin 3 months after enrolment
Patients expected to have kidney transplant whithin 3 months after enrolment