Vildalgliptin use in Type 2 Diabetes

• Conditions: Diabetes and Cardiac risk benefit in South Asians.; MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-006049-14-GB
• Lead Sponsor: The University of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Type 2 diabetes of at least 6 months duration; HbA1c should be 7-9%.
2. Established on metformin and sulphonylurea combination therapy for at least 3 months
3. Body mass index from 25 kg/m2 to 45 kg/m2
4. Stable body weight (<10% variation for the 3 months prior to screening
5. Age between 18 and 75 years:
6. Women of childbearing potential must be using contraception to prevent pregnancy

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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

1. Nursing mothers, pregnant women (excluded by a negative pregnancy test).
2. Patients with a history of drug/alcohol abuse
3. Abnormal liver function tests
4. Severe chronic renal failure (GFR<50 ml/min) or diabetic nephropathy
5. previous/ known hypersensivity to Vildalgliptin or any other substance in the study medic ation.
6. Failure to provide informed consent

Study & Design

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