Diabetes mellitus type 2
Conditions
Interventions
Continuing sulfonylurea with a combination of metformin and insulin glargine versus discontinuing sulfonylurea with this combination.
Sponsors
De Stichting Julius Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes patients, male and female, insulin naive, without good glycaemic control for at least 3 months despite combination of metformin and sulfonylurea therapy and who are refererred for insulin therapy by their GP; 2. Age: 40-75 years; 3. HbA1c >=7,5%.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes; 2. C-peptide 2 times normal) and/or kidney (creatinin >135 male, > 110 female) problems; 4. Patients who do not read Dutch good enough to answer questionnaires; 5. Pregnancy/lactation; 6. Amputation (leg, arm); 7. Intercurrent disease at the discretion of the investigator; 8. Short life expectancy; 9. Contraindications/intolerancies for metformin, sulfonylurea or insulin glargine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the two groups in the remaining insulin secretion of the beta-cells, assessed by the difference in HOMA-beta and in fasting C-peptide. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in mean daily dosage of insulin glargine in order to reach good glycaemic control (HbA1c <= 7,0%); 2. Percentage of patients with good glycaemic control after 12 months; 3. Percentage of patients with good glycaemic controle at several intervals within 12 months; 4. Frequency of serious and of nocturnal hypoglycaemic episodes; 5. Waist circumference; 6. Quality of life; 7. Patients' treatment satisfaction. | — |
Contacts
Public ContactM.J.P. Avendonk, van
University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care, Stratenum 6.131, P.O. Box 85500
Outcome results
None listed