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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-003723-21-IT
• Date of registration: 13/11/2007
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: 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
• Scientific title: 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
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003723-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: Other: no

Countries of recruitment

Finland, France, Germany, Italy, Spain, Sweden

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes and moderate renal insufficiency
MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus

Intervention(s)

Product Name: vildagliptin
Product Code: LAF237A
Pharmaceutical Form: Tablet
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: vildagliptin
Product Code: LAF237A
Pharmaceutical Form: Tablet
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the safety and tolerability of vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with T2DM and moderate renal insufficiency over 24 weeks of treatment.

Primary end point(s): Assessment of safety and tolerability of vildagliptin (50 mg or 100 mg) versus placebo in patients with T2DM and moderate renal insufficiency over 24 weeks of treatment. The variables for the primary objectives include treatment emergent adverse events (including hypoglycemia events and events of special interest), serious adverse events. Biochemistry and hematology laboratory test results, ECG findings, and vital signs/body weight will also be assessed.

Secondary Objective: To explore the relationship between renal function and concentration levels of vildagliptin and its metabolites, after repeated doses of vildagliptin (50 mg qd and 100 mg qd) in patients with T2DM and moderate renal insufficiency. To explore the efficacy of vildagliptin (50 mg qd and 100 mg qd) versus placebo in patients with T2DM and moderate renal insufficiency by assessing the hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 24 weeks of treatment.

Secondary ID(s)

CLAF237A23137

2007-003723-21-SE