A multi-centre, randomised, double blind, parallel group study to investigate the efficacy and tolerability of treatment (24 weeks double blind phase followed by open-label extension) with either vildagliptin ( Galvus) or placebo combined with metformin in achieving optimal glycaemic control in older patients with type 2 diabetes.

Phase 1

• Conditions: Type 2 Diabetes

• Registration Number: EUCTR2007-001049-16-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-10
• Study Completion: 2008-08-27
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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 < 45ml/min as calculated by the MDRD formula then the patient should be excluded from the study
11.Chronic insulin treatment (> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified