Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCH-05-015
Study information
Scientific title
A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis
Acronym
Study hypothesis
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
West Midlands Research Ethics Committee, 17/10/2005
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/10/2006
Overall trial end date
01/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
240
Participant exclusion criteria
1. Failure to provide informed consent
2. Pre-existing insulin or oral hypoglycaemic agent treatment
Recruitment start date
01/10/2006
Recruitment end date
01/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom
Sponsor information
Organisation
Sheffield Children's NHS Foundation Trust (UK)
Sponsor details
Clinical Research Support Unit
D41 Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2260507
vee.mapunde@sch.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Society of Paediatric Endocrinology and Diabetes (UK) - Initial funding of £10,000 in November 2004
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sheffield Children's Appeal Charity (UK) - £32,000 in early 2005
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novo Nordisk (UK) - the makers of Detemir; £72,000 (post MREC approval) in summer 2005
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
Basic results (scientific)
Publication list