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Insulin combination therapy in type 2 diabetes.


- candidate number2063
- NTR NumberNTR660
- ISRCTNISRCTN29335793
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR19-apr-2006
- Secondary IDsN/A 
- Public TitleInsulin combination therapy in type 2 diabetes.
- Scientific TitleFailure of metformin and sulfonylurea combination therapy: should we stop or continue the use of sulfonylurea in combination with insulin glargine in type 2 diabetes patients in primary care?
- ACRONYMDIASULIN
- hypothesisContinuing 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2006
- planned closingdate1-apr-2007
- Target number of participants200
- InterventionsContinuing sulfonylurea with a combination of metformin and insulin glargine versus discontinuing sulfonylurea with this combination.
- Primary outcomeDifference 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 outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. M.J.P. Avendonk, van
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. G.E.H.M. Rutten
- Sponsor/Initiator Stichting Julius Research
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis
- PublicationsN/A
- Brief summaryThe 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 na´ve 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.
- Main changes (audit trail)
- RECORD19-apr-2006 - 2-jun-2012


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