Diabetes in the Very Elderly Trial - DIVET

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: EUCTR2005-001027-11-GB
• Lead Sponsor: niversity Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Men and women over the age of 75 at the time of randomisation.
2) After 2 months of dietary treatment, a HbA1c equal to or greater than 7.5 - equal to or less than 9.0%.
3) Informed written consent.
4) No symptom due to uncontrolled diabetes such as recent weight loss, polyuria, thirst or recurrent infection.
5) No serious diabetic complication such as proliferative retinopathy or sight threatening retinopathy.
6) No serious cardiovascular event in the previous 2 months.
7) No life threatening disease which is likely to lead to an early demise.
8) If previously treated with anti diabetic drugs these should have been stopped at least 2 months previously.
9) Abbreviated Mental Test Score (MTS) >=7 out of 10 of 5 or 6 the carer to also give informed assent.
10) Inclusion for metformin treatment
i) serum creatinine <130umol/1
ii) no alcohol abuse (normal liver transaminases)
iii) no congestive heart failure (doses of up to 40mg of Frusemide or equivalent acceptable).
iv) no liver disease (normal transaminases)
v) any B12 deficiency must be corrected.
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) Age less than 75 years.
2) Patient with terminal illness.
3) Presence of symptoms due to uncontrolled diabetes (recent weight loss, polyuria, thirst or recurrent infection).
4) Serious diabetic complication (proliferative retinopathy, sight threatening retinopathy).
5) Serious cardiovascular event in the previous 2 months.
6) Life threatening disease which is likely to lead to early demise.
7) Previous demonstration of a definite need for good blood sugar control eg. lactic acidosis.
8) Unable to provide informed written consent or consent withheld by the principal carer.

Study & Design

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