Type 2 diabetes
Conditions
Interventions
Trade Name: Galvus® 50 mg Tabletten
Product Name: Vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: Vildagliptin
CAS Number: 274901-16-5
Current Sponsor code: LAF237
C
Sponsors
Novartis Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the extension study 2. Age in the range of 18-85 years inclusive at visit 1 3. 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 an AGI can only enter the study if their GFR is =30 mL/min; in addition, each country should comply with its local label for the use of AGIs in patients with renal impairment 4. 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) 5. GFR estimated by the Cockcroft-Gault formula =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Premature discontinuation from the core study 2. Concomitant medical conditions that interfere with the interpretation of the study results as defined in the core protocol. 3. Failure to comply with the core study protocol per the judgment of the investigator 4. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long term safety and tolerability of vildagliptin 50 mg qd versus placebo in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment.;Secondary Objective: Exploratory objective(s) : To explore the long term efficacy of vildagliptin 50 mg qd versus placebo in patients with T2DM and moderate or severe renal insufficiency by assessing the hemoglobin A1c (HbA1c)and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment.;Primary end point(s): The variables for the primary objectives include treatment emergent adverse events (including hypoglycemia events and events of special interest) and serious adverse events. Biochemistry and hematology laboratory test results, ECG findings and vital signs/body weight will also be assessed. | — |
Countries
Finland, France, Germany, Spain, Sweden
Outcome results
None listed