Diabetes Type 2
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age in the range of 18-85 years inclusive at visit 1 2. 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, AGIs, TZDs, insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1 3. 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) 4. GFR estimated by the Cockcroft-Gault formula of = 30 and 40 mLU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation • A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means • Medically approved birth control methods may include: hormonal contraceptives, intrauterine contraceptive device (IUD), and double-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Reliable contraception should be maintained throughout the study 8. Agreement to continue their current diet/exercise regimen and sulfonylurea, AGI, TZD, insulin, or metiglinide therapy throughout the duration of the study or to remain untreated if patient is not taking anti-diabetic therapy, unless otherwise instructed by the trial’s physician 9. Written informed consent to participate in the study and ability to comply with all study requirements 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: 1. FPG = 270 mg/dL (=15 mmol/L) 2. Pregnant or lactating female 3. A history of: • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months 4. Patients that have been enrolled in a vildagliptin clinical trial or other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within six months prior to visit 1 5. History of renal transplant at any time in the past 6. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study 7. Any pre-existing lower extremity diabetic skin ulcer 8. Patients taking TZDs with established peripheral edema 9. Congestive heart failure (New York Heart Association (NYHA) class III-IV) 10. Any of the following within the past 6 months: • myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the clinical trial at the discretion of the investigator and/or local medical monitor); • unstable angina • coronary artery bypass surgery or percutaneous coronary intervention; • stroke 11. Any of the following ECG abnormalities: • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation • second degree AV block (Mobitz 1 and 2) • third degree AV block • prolonged QTc (> 500 ms) 12. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years 13. Liver disease such as cirrhosis or chronic active hepatitis B and C 15. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study 16. Any of the following concomitant medications: • any anti-diabetic therapy other than sulfonylureas, AGIs, TZDs, insulin, and metiglinides within 8 weeks prior to visit 1 • chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1 • treatment with class Ia, Ib and Ic or III anti-arrhythmics • treatment with growth hormone or similar drugs • treatment with probenecid • treatment with any medication that is contraindicated in the renal impaired population (GFR 500 mg/dL at visit 1, confirmed by a repeat measure within 3 working days • Alanine aminotransferase (ALT) and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment. ;Secondary Objective: Exploratory objective(s) • To explore the relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin (50 mg qd) in patients with T2DM and moderate or severe renal insufficiency. • To explore the 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 24 weeks of treatment. ;Primary end point(s): Assessment of 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. 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. | — |
Countries
Finland, France, Germany, Spain, Sweden
Outcome results
None listed