Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Product Name: Saxagliptin 2.5 mg
Product Code: BMS-477118-11
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: saxagliptin
CAS Number: 361442-04-8
Current Sponsor code: BMS-477118-11
Concen
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria: At visit 1: Pregnancy or breastfeeding Initiation of 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 Treatment with thiazolidinedione within 12 weeks prior to visit 1 Systemic treatment with oral prednisolone above 10 mg per day 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 History of positive serologic evidence of current infectious liver disease Anemia Clinically significant abnormality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): The first 12 weeks of treatment will be used for the primary assessment of treatment effect and tolerability, after which the following 40 weeks will be used to assess the long-term efficacy, safety and tolerability. The primary variable is absolute change from baseline in HbA1c level at week 12.;Main Objective: Short-term: To evaluate the efficacy of saxagliptin 2.5 mg in adult patients with type 2 diabetes and renal impairment (moderate, severe and end-stage) compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose To evaluate the safety and tolerability of saxagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examination To characterize the PK properties of saxagliptin Long-term: To evaluate the safety and tolerability of sagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examiniation To evaluate the efficacy of oral treatment with saxagliptin 2.5 mg compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose To assess the change from baseline in background anti-diabetic therapy | — |
Countries
Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania
Outcome results
None listed