Patients with type 2 diabetes, who are treated with insulin and metformin .
Conditions
Interventions
Trade Name: Amaryl
Product Name: Amaryl
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital. Division of internal medi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Typ 2 diabetes with duration = 10 years BMI 24-40 kg/m2 Hba1c 6,0%-8,5 % Ongoing treatment with insulin and Metformin since at least 1 year. If a woman in fertil age is included, a safe anticonception is to be used. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Renal impairement (creatinine levels> 130µmol/l) Hepatic insufficiency (transaminases > 3 times the normal value) Fasting C-peptide/plasma glucose ratio < 0,052 Inability to perform self monitoring of blood glucose Therapy with Sulfonylureas within 1 year prior to inclusion Known intolerability to glimepiride Untreated proliferative retinopathy Pregnancy or women in fertil age without a safe anticonception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of adding glimepiride to ongoing therapy (insulin and metformin) on glycemic control in patients with type 2 diabetes.;Secondary Objective: Change in fasting plasma glucose Change in insulin dose (units/kg) Basal and stimulated C-peptide RatioCPT/glucose, fasting and postprandial Change in body weight Rate of hypoglycemia Glucose profiles measured by using CGMS device;Primary end point(s): Change in HbA1c | — |
Countries
Sweden
Outcome results
None listed