A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with type 2 diabetes and moderate renal insufficiency - ND

• Conditions: Type 2 Diabetes and moderate renal insufficiency; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2007-003723-21-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Age in the range of 18-85 years inclusive at visit 1 Patients with T2DM either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to visit 1) or treated with anti-diabetic therapy defined as sulfonylurea, alpha-glucosidase inhibitors (AGIs), thiazolidinediones (TZDs), insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1 Patients treated with anti-diabetic therapy must be on a stable dose for the past 4 weeks prior to visit 1 (stable insulin therapy is defined as ± 20% of total daily units) GFR estimated by the Cockcroft-Gault formula of ≥ 30 and <50 mL/min at visit 1 HbA1c of ≥ 6.5 and ≤ 10% at visit 1 Body weight < 120 kg and body mass index (BMI) 18-42 kg/m2 at visit 1
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

FPG ≥ 270 mg/dL (≥15 mmol/L) Pregnant or lactating female History of renal transplant at any time in the past Any pre-existing lower extremity diabetic skin ulcer Patients taking TZDs with established peripheral edema Congestive heart failure (New York Heart Association (NYHA) Class III-IV) Liver disease, such as cirrhosis, or chronic active hepatitis B and C Patients undergoing any method of dialysis (hemodialysis or peritoneal dialysis) or on the dialysis list at visit 1 Treatment with current anti-diabetic therapy other than sulfonylureas, AGIs, TZDs insulin, and metiglinides within 8 weeks prior to visit 1 Treatment with any medication that is contraindicated in the renal impaired population (GFR < 50 mL/min: calculated by the Cockcroft-Gault formula) Any of the following significant laboratory abnormalities: Clinically significant thyroid stimulating hormone (TSH) outside of normal range at visit 1 Clinically significant laboratory abnormalities at the opinion of the investigator Patients with a serum albumin < 3.0 g/dL at visit 1 Patients with a hemoglobin concentration < 9 g/dL at visit 1 Elevated fasting triglycerides > 500 mg/dL at visit 1, confirmed by a repeat measure within 3 working days Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at visit 1, confirmed by a repeat measure within 3 working days Total bilirubin > 2 x ULN and/or direct bilirubin greater than the ULN at visit 1, confirmed by a repeat measure within 3 working days History of spontaneous or drug induced muscle symptoms (not associated with exercise and/or physical activity), and/or elevated CPK (> 3 x ULN) confirmed by a repeated measure within 3 working days A positive Hepatitis B test (surface antigen - HbsAg) A positive Hepatitis C test (HCV antibodies)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified