Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/09/2006
Date assigned
27/06/2007
Last edited
15/03/2016
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 Neil Wright

ORCID ID

Contact details

Sheffield Children's NHS Foundation Trust
Academic Unit of Child Health
C Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom

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 measures

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

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

http://www.sheffieldchildrens.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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