A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis

ISRCTN ISRCTN71877586
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

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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis
Study objectivesTo 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) studiedCystic Fibrosis Related Diabetes mellitus (CFRD)
InterventionChildren 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Insulin detemir
Primary outcome measureMeasurements of beta-cell function
Secondary outcome measures1. 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 date01/10/2006
Completion date01/11/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit10 Years
SexBoth
Target number of participants240
Key inclusion criteriaAny 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 criteria1. Failure to provide informed consent
2. Pre-existing insulin or oral hypoglycaemic agent treatment
Date of first enrolment01/10/2006
Date of final enrolment01/11/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom

Sponsor information

Sheffield Children's NHS Foundation Trust (UK)
Hospital/treatment centre

Clinical Research Support Unit
D41 Stephenson Wing
Western Bank
Sheffield
S10 2TH
England
United Kingdom

Phone +44 (0)114 2260507
Email vee.mapunde@sch.nhs.uk
Website http://www.sheffieldchildrens.nhs.uk/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

15/03/2016: No publications found, verifying study status with principal investigator