Continuing sulfonylurea in patients without good glycaemic control and using insulin and metformin, will diminish insulin secretion of beta-cells less than discontinuing sulfonylurea in these patients.
ID
Bron
Verkorte titel
Aandoening
Diabetes mellitus type 2
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
The purpose of this study is to investigate the effect of continuing sulfonylurea with a combination of metformin and insulin glargine versus discontinuing sulfonylurea with this combination in insulin naïve patients in primary care. We investigate several aspects: remaining insulin secretion of beta-cells, mean daily dosage of insulin glargine, percentage of patients with good glycaemic control at several time intervals, frequency of nocturnal and serious hypoglycaemic episodes, waist circumference, quality of life and treatment satisfaction.
Doel van het onderzoek
Continuing sulfonylurea in patients without good glycaemic control and using insulin and metformin, will diminish insulin secretion of beta-cells less than discontinuing sulfonylurea in these patients.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Continuing sulfonylurea with a combination of metformin and insulin glargine versus discontinuing sulfonylurea with this combination.
Publiek
P.O. Box 85500
M.J.P. Avendonk, van
Utrecht 3508 GA
The Netherlands
+31 (0)30 2538608
m.j.p.vanavendonk@umcutrecht.nl
Wetenschappelijk
P.O. Box 85500
M.J.P. Avendonk, van
Utrecht 3508 GA
The Netherlands
+31 (0)30 2538608
m.j.p.vanavendonk@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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%.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Type 1 diabetes;
2. C-peptide < 0,50 nmol/l;
3. Liver (ASAT/ALAT >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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL604 |
| NTR-old | NTR660 |
| Ander register | : N/A |
| ISRCTN | ISRCTN29335793 |