Type II diabetes mellitus inadequate control MedDRA version: 9.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method. 2. Patients with T2DM who have received metformin for at least three months prior visit 1 and have been on a stable (maximal tolerated) dose for a minimum of 8 weeks prior to visit 1. 3. Agreement to maintain the same dose of metformin throughout the study. 4. Age in the range of 18-85 years inclusive. 5. HbA1c in the range of 6.5 – 8.0 % (inclusive) at visit 1. 6. Agreement to maintain prior diet and exercise habits during the full course of the study. 7. Ability to comply with all study requirements and signed informed consent to participate in the study. 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. 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. 2. Evidence of significant diabetic complications, e.g. symptomatic autonomic neuropathy or gastroparesis. 3. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical conditions that may interfere with the interpretation of efficacy and safety data during the study. 4. A history of: • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation. • 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 study at the discretion of the investigator and the sponsor); coronary artery bypass surgery; percutaneous coronary intervention, unstable angina; or stroke. 5. Congestive heart failure requiring pharmacologic treatment. 6. Any of the following ECG abnormalities: • second degree AV block (Mobitz 1 and 2) • third degree AV block • prolonged QTc (> 500 ms) 7. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 8. Body mass index (BMI) outside 22- 40 kg/ m2 at visit 1 9. Liver disease such as cirrhosis or chronic active hepatitis. 10. Significant renal dysfunction (see also exclusion criteria 20 laboratory abnormalities). 11. Donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 12. Contraindications and warnings according to the country specific label for metformin not listed in the other exclusion criteria. 13. Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1 14. Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months. 15. Treatment with growth hormone or similar drugs. 16. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 17. Treatment with class Ia, Ib and Ic or III anti-arrhythmics. 18. Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1, whichever is longer, unless local health authority guidelines mandate a longer period. 19. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e. cytostatic drugs). 20. Any of the following significant laboratory abnormalities: • ALT, AST greater than 3 times the upper limit of the normal range at visit 1. • Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1. • Serum creatinine levels = 1.5 mg/dL (132 ?mol/L) males, = 1.4 mg/dL (123 ?mol/L) females, or a history of abnormal creatinine clearance at visit 1. • Clinically significant TSH values outside of normal range at visit 1. • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1. 21. History of substance abuse (including alcoh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of vildagliptin 100 mg add-on therapy in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the HbA1c reduction with vildagliptin 100 mg o.a.d. (hierarchically testing of pooled data of a.m. and p.m. dose as well as within a.m. and p.m. dosing groups) is superior to that with placebo after 24 weeks of treatment.;Secondary Objective: 1. To confirm the efficacy of add-on therapy with vildagliptin in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the FPG reduction with vildagliptin 100 mg o.a.d. (pooled data of a.m. and p.m dose as well as within a.m. and p.m. dosing groups) is superior to that with placebo after 24 weeks of treatment. 2. To confirm the safety of vildagliptin in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by showing that add-on therapy with vildagliptin 100 mg o.a.d. (pooled data of a.m and p.m. dosing) has comparable AE profiles including gastrointestinal (GI) tolerability and hypoglycemia to placebo during 24 weeks of treatment. ;Primary end point(s): The primary efficacy variable is change from baseline in HbA1c at Week 24 or at the final visit with HbA1c measurement for those patients who do not have a Week 24 HbA1c measurement (the last observation carried forward (LOCF) approach). | — |
Countries
Germany
Outcome results
None listed