Insulin combination therapy in type 2 diabetes
| ISRCTN | ISRCTN29335793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29335793 |
| Secondary identifying numbers | N/A |
- 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
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 |
|---|---|
| m.j.p.vanavendonk@umcutrecht.nl |
Study information
| Study design | Randomised controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metformin, sulfonylurea, insulin glargine |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
3508 GA
Netherlands
Sponsor information
Stichting Julius Research (The Netherlands)
Research organisation
Research organisation
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2509358 |
|---|---|
| juliuscenter@azu.nl | |
"ROR" |
https://ror.org/0575yy874 |
Funders
Funder type
Industry
Sanofi-Aventis
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
