A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis
ISRCTN | ISRCTN71877586 |
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DOI | https://doi.org/10.1186/ISRCTN71877586 |
Secondary identifying numbers | SCH-05-015 |
- Submission date
- 19/09/2006
- Registration date
- 27/06/2007
- Last edited
- 15/03/2016
- 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 Neil Wright
Scientific
Scientific
Sheffield Children's NHS Foundation Trust
Academic Unit of Child Health
C Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis |
Study objectives | To establish a better methodology for identifying patients with Cystic Fibrosis Related Diabetes mellitus (CFRD) and to show that early treatment produces clinical benefits. |
Ethics approval(s) | West Midlands Research Ethics Committee, 17/10/2005 |
Health condition(s) or problem(s) studied | Cystic Fibrosis Related Diabetes mellitus (CFRD) |
Intervention | Children will be randomised to receive Insulin detemir 0.2 units per kg body weight by once daily subcutanous injection daily for one year. The control group will receive no intervention. There is no placebo or sham treatment (it was not felt appropriate given that it would require a daily injection). |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Insulin detemir |
Primary outcome measure | Measurements of beta-cell function |
Secondary outcome measures | 1. Height, weight, Body Mass Index (BMI), triceps and biceps skin fold thickness 2. Respiratory function testing 3. Three monthly glycosylated haemoglobin 4. Adverse event monitoring |
Overall study start date | 01/10/2006 |
Completion date | 01/11/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 10 Years |
Sex | Both |
Target number of participants | 240 |
Key inclusion criteria | Any child over ten years of age with either fasting plasma glucose more than 6.1 mmol/l but less than 7.0 mmol/l and/or a two hour glucose of more than 7.8 mmol/l but less than 11.1 mmol/l. |
Key exclusion criteria | 1. Failure to provide informed consent 2. Pre-existing insulin or oral hypoglycaemic agent treatment |
Date of first enrolment | 01/10/2006 |
Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Sheffield Children's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Clinical Research Support Unit
D41 Stephenson Wing
Western Bank
Sheffield
S10 2TH
England
United Kingdom
Phone | +44 (0)114 2260507 |
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vee.mapunde@sch.nhs.uk | |
Website | http://www.sheffieldchildrens.nhs.uk/ |
https://ror.org/02md8hv62 |
Funders
Funder type
Charity
British Society of Paediatric Endocrinology and Diabetes (UK) - Initial funding of £10,000 in November 2004
No information available
Sheffield Children's Appeal Charity (UK) - £32,000 in early 2005
No information available
Novo Nordisk (UK) - the makers of Detemir; £72,000 (post MREC approval) in summer 2005
No information available
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
15/03/2016: No publications found, verifying study status with principal investigator