Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
19/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.J.P. Avendonk, van

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2538608
m.j.p.vanavendonk@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DIASULIN

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Metformin, sulfonylurea, insulin glargine

Primary outcome measures

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 trial start date

01/04/2006

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant 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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/04/2006

Recruitment end date

01/04/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

Stichting Julius Research (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2509358
juliuscenter@azu.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Sanofi-Aventis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes