Type 2 Diabetes Mellitus
Conditions
Interventions
Trade Name: Glucophage
Product Name: Metformin
Pharmaceutical Form: Film-coated tablet
Trade Name: Diamicron 30mg MR
Product Name: Gliclazide MR
Pharmaceutical Form: Tablet
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To pilot a multicentre morbidity and mortality study of treating type 2 diabetes in asymptomatic patients over the age of 75. Patients will be randomised to receive oral hypoglaecymic drugs or no drugs. The endpoints of the pilot study are the number of patients that withdraw from active treatment due to adverse effects and the number of the control patients who are admitted with ketoacidosis or hyperosmolar coma. The pilot study will also test the recruitment strategy, data collection, adverse biochemical events and hyperglycaemic control. The end point rates are 10%, 100 patients in each group will give 95% confidence levels of 4.9%, 17.6% with 80% power. The ultimate aim is to establish the risk to benefit ratio of using oral hypoglycaemic agents in the very elderly in a full trial.;Secondary Objective: We will collect data on the development of diabetes-related complications including infection rates, hospital admissions and weight changes.;Primary end point(s): 1. Adverse drug effect rates (hypoglycaemic episodes and severe side effects such as serious gastrointestinal disturbances). 2. The development of keto-acidosis or hyperosmolar diabetic coma. 3. The development of lactic acidosis. 4. The number requiring hypoglycaemic treatment due to symptoms such as thirst, polyuria and persistent infections. 5. Development of diabetic complications, retinal bleeds, renal failure, or persistent foot infections. 6. Hospital admissions due to diabetes or a diabetes-related event. 7. Weight change greater than 10% of baseline. 8. The following will be recorded but not part of the primary analysis: number of morbid or mortal cardiovascular events; total mortality. | — |
Countries
United Kingdom
Outcome results
None listed