Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
01/09/2014
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

Ms Diane Picton

ORCID ID

Contact details

Addenbrooke's Hospital
Department of Paediatrics
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

2007-004144-74

ClinicalTrials.gov number

Protocol/serial number

4903

Study information

Scientific title

A comparison of the effects of insulin Detemir with insulin Glargine on weight gain in female adolescents and young adults with type 1 diabetes on a basal bolus regime

Acronym

DETEMIR GLARGINE

Study hypothesis

To explore the hypothesis that use of insulin detemir versus insulin glargine will lead to reduced weight gain in young women with T1D.

Ethics approval

Oxfordshire REC A, 26/10/2008, ref: 07/H0604/122

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Medicines for Children Research Network, Diabetes Research Network; Subtopic: Type 1, All Diagnoses; Disease: All Diseases, Insulin switch, Metabolic, Paediatric

Intervention

1. Lantus® Optiset (600 nmol/ml [100 IU/ml] in 3 ml pre-filled, disposable pen device) dosage variable/subcut/frequency once or twice day
2. Lantus® Solostar (600 nmol/ml [100 IU/ml] in 3 ml pre-filled, disposable pen device) dosage variable/subcut/frequency once or twice day
3. Levemir® FLEX-PEN (2400 nmol/ml [100 U/ml] in 3 ml pre-filled, disposable pen device) dosage variable/subcut/frequency once or twice day

Duration of treatment: one year
Duration of follow-up: No follow-up
Study entry: single randomisation only

Intervention type

Drug

Phase

Phase III

Drug names

Determir, glargine

Primary outcome measures

Reduced weight gain. Full body dual energy x-ray absorptiometry (DEXA) will be done at baseline and 1 year.

Secondary outcome measures

To explore differences between the two insulins on the following:
1. HBa1c
2. Fat mass

Study bloods will be taken at baseline, 6 and 12 months.

Overall trial start date

01/04/2008

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 diabetes (T1D) duration greater than 1 year or C peptide negative
2. Females, postmenarchal, 13 - 20 years of age
3. HbA1c less than 12%
4. Body mass index (BMI) SDS less than or equal to +2.5
5. On basal bolus regime
6. No active or untreated concurrent disease

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 112; UK sample size: 112

Participant exclusion criteria

1. Non-T1D including those secondary to chronic disease
2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and intepretation of the study results
3. Pregnant or breastfeeding women
4. Females of reproductive age who are unwilling to take appropriate measures of contraception

Recruitment start date

01/04/2008

Recruitment end date

30/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Box 277
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Not defined

Website

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Industry

Funder name

Novo Nordisk Pharmaceuticals Limited (UK)

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