Type 2 Diabetes
Conditions
Sponsors
Novartis Pharmaceuticals UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or Female; (65 to 80 years old); patients with T2DM (diagnosed at least 3 months prior to visit 1) who have received metformin 500mg BD- 2000mg daily divided dose of metformin monotherapy for at least three months immediately prior to visit 1 body mass index of 20-45.0kg/m2 inclusive at visit 1 HbA1c from 6.6 - 8.0% inclusive at visit 1. FPG,15mmol/L; written informed consent to participate in the study . Male or non-fertile female A non fertile female is defined as: post menopausal ( 12 months of natual (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40mIU/m); 6 weeks post bilateral oophorectomy with or without hysterctomy;or sterilised by tubal ligation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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, gastroparesis, as well as symptoms of worsening hyperglycaemia (i.e. polyuria, polydipsia, weight loss) in the absence of any intercurrent illness or other incidental circumstances potentially causing deterioration of glucose control. 3. 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. 4. Any of the following within the past 6 months: • myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with an old 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 or percutaneous coronary intervention; • unstable angina that is not pharmacologically controlled or stroke. • TIA in the last 6 months 5. Congestive heart failure (CHF) requiring pharmacological treatment other than loop diurectics, digoxin, ARB or any beta blocker. 6. 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 msec) 8. Malignancy including leukaemia and lymphoma (not including basal cell skin cancer) within the last 5 years. 9. Liver disease such as cirrhosis or chronic active hepatitis. 10. Contraindications and warnings according to the UK label for metformin not listed in the other exclusion criteria. • If eGFR 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months. 12. Treatment with other oral antidiabetics within 3 months prior to visit 1. 13. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 14. Treatment with growth hormone or similar drugs. 15. Treatment with class Ia, Ib and Ic or III anti-arrhythmics. 16. 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. 17. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e., cytostatic drugs). 18. Any of the following significant laboratory abnormalities: • ALT, AST greater than 2 times the upper limit of the normal range at visit 1, confirmed by a repeat test within 3 working days. • Total bilirubin greater than 2 times the upper limit of the normal range at visit 1 and direct bilirubin greater than the upper limit of normal range at visit 1, confirmed by a repeated measure within 3 working days. Hepatitis B or C positive (on blood test) • Clinically significant renal dysfunction as indicated by MDRD eGFR < 45ml/min. • Clinically significant TSH values outside of normal range at visit 1. • Clinically significant laboratory abnormalities, confirmed by
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superior HbA1c control rates (where control is defined as HbA1c= or 7.0%) and ii) HbA1c =or 7.5% To investigate whether there is a comparable lipid profile To investigate whether there are comparable overall adverse event, particularly hypoglycaemic episodes and discotinuation rates. To investigate differeces in GI symptoms, as defined by the Gastrointestinal Symptoms Reporting scale. To compare changes in FPG (fasting plasma glucose) ;Primary end point(s): Hba1C control rate (where control is defined as HbA1C=< 6.5% after 24 weeks treatment (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 approach) in subjects given vildagliptin added to metformin compared to those given placebo combined with metformin for the overall ITT population. | — |
Countries
United Kingdom
Outcome results
None listed