Effect of glimepiride on glycemic control in patients with typ 2 diabetes treated with insulin and metfromi

Active, not recruiting

Conditions: Patients with type 2 diabetes, who are treated with insulin and metformin .

Registration Number: EUCTR2008-001092-29-SE

Lead Sponsor: Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital. Division of internal medi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Change in insulin dose (units/kg)<br>Basal and stimulated C-peptide<br>RatioCPT/glucose, fasting and postprandial<br>Change in body weight<br>Rate of hypoglycemia<br>Glucose profiles measured by using CGMS device;Primary end point(s): Change in HbA1c

Secondary Outcome Measures