Insulin combination therapy in type 2 diabetes

ISRCTN	ISRCTN29335793
DOI	https://doi.org/10.1186/ISRCTN29335793
Protocol serial number	N/A
Sponsor	Stichting Julius Research (The Netherlands)
Funder	Sanofi-Aventis

Submission date: 19/07/2006
Registration date: 19/07/2006
Last edited: 19/07/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.J.P. Avendonk, van
Scientific

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2538608
Email	m.j.p.vanavendonk@umcutrecht.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DIASULIN
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes mellitus type 2 (DM type II)
Intervention	Continuing sulfonylurea with a combination of metformin and insulin glargine versus discontinuing sulfonylurea with this combination.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Metformin, sulfonylurea, insulin glargine
Primary outcome measure(s)	Difference between the two groups in the remaining insulin secretion of the beta-cells, assessed by differences in Homeostasis Model Assessment (HOMA)-beta and in fasting C-peptide.
Key secondary outcome measure(s)	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 control 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
Completion date	01/04/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Type 2 diabetes patients, male and female, insulin naive, without good glycaemic control for at least three months despite combination of metformin and sulfonylurea therapy and who are referred for insulin therapy by their general practitioner (GP) 2. Aged 40-75 years 3. Haemoglobin HbA1c (HbA1c) >=7.5%
Key exclusion criteria	1. Type 1 diabetes 2. C-peptide <0.50 nmol/l 3. Liver (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 times upper limit of normal) and/or kidney (creatinine >135 in male patients, >110 in female patients) problems 4. Patients who do not read Dutch well enough to answer questionnaires 5. Pregnancy or lactation 6. Amputated leg or arm 7. Intercurrent disease at the discretion of the investigator 8. Short life expectancy 9. Contraindications or intolerancy to metformin, sulfonylurea or insulin glargine
Date of first enrolment	01/04/2006
Date of final enrolment	01/04/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan