Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
22/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a life-long condition where a person is unable to control their blood sugar levels. here are two main types of diabetes. In type 1 diabetes the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. When this happens, sufferers need to inject insulin to make sure that their blood sugar levels stay normal. Most people use long-acting insulin to give a continuous low level in the blood stream and a short acting insulin to give a “boost” at meal times. There are several different types of insulin made. This study is looking at the differences between two relatively new insulins, called Detemir (or Levemir) and another one called Glargine (or Lantus). Although it is normal to gain weight with age, girls with diabetes may have more weight gain than girls without diabetes. Levemir appears to cause less weight gain than insulatard (the conventional ‘cloudy’ long acting insulin) in adults and young people with diabetes, but it has never been compared with Lantus in young women. The aim of this study is to find out whether there are any differences in weight gain in young women using these different types of insulin.

Who can participate?
Girls aged between 13 and 20 with T1DM.

What does the study involve?
Participants who agree to take part in the study are randomly allocated to receive either Insulin Detemir (Levemir) or Insulin Glargine (Lantus). The study lasts for one year and involves six clinic visits and regular telephone and/or email contact (minimum 12) with the research nurse. At each visit the participant’s height, weight, blood pressure and waist circumference are measured. The participants are also asked to complete a brief questionnaire about appetite. During the study, participants are asked to check and record their blood sugar before breakfast, their evening meal, before bedtime, and whenever they feel as if their blood sugars are low. At two months, participants are asked to record their blood sugar values on a 5 point profile (breakfast, lunch, evening meal, bedtime and once overnight at around 0200h). In centres which have the necessary equipment, after 3 months and at the very end of the study, glucose values for three days, using a continuous glucose monitoring sensor, are recorded. The sensor is a small electrode that lies just beneath the skin and can convert tiny amounts of glucose into a signal that is sent and stored by the monitor which is downloaded into a computer file. At the beginning and end of the study, where appropriate facilities are available, participants are asked to have a scan to measure body fat distribution. Four times throughout the study; at the beginning, end and after three and six months, blood samples are taken to assess overall glucose control over the preceding three months and levels of other hormones within the blood, such as testosterone, which may vary in young women with diabetes. Anyone can have anaesthetic (numbing) cream applied to the skin before the blood test is done if they prefer.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk of pain, bruising or infection when blood samples are taken using blood tests or the continuous glucose monitoring sensor.

Where is the study run from?
Addenbrooke's Hospital and 24 other hospitals in England (UK)

When is the study starting and how long is it expected to run for?
September 2005 to January 2017

Who is funding the study?
Novo Nordisk Pharmaceuticals Limited (UK)

Who is the main contact?
Ms Diane Picton
dp223@medschl.cam.ac.uk

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
+44 1223 768613
dp223@medschl.cam.ac.uk

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

The aim of this study is 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

See additional files

Condition

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

Intervention

Interventions as of 22/05/2017:
Eligible subjects will be randomised to one of two groups using an internet based service (www.sealedenvelope.com) with minimisation of variation in:
1. Age (< or ≥ 16yrs)
2. BMI SDS (< or ≥ 1 SDS)
3. HbA1c (< or ≥ 8 % or 64mmol/mol)
4. Years post menarche (< or ≥ 2yrs)
5. Centre
Randomisation will be 1:1 between the arms. The web based randomisation service is password protected on a secure server and no identifiable patient details will be entered. Following randomisation, a completed form, confirming treatment will be faxed back to the local research team. The local team will then notify their pharmacist in order to facilitate local dispensing prior to the participant attending for their baseline visit.

Group 1: Participants receive Levemir®. 1 ml of the solution contains 100 U insulin detemir* (equivalent to 14.2 mg). 1 pre-filled pen contains 3 ml equivalent to 300 U
Group 2: Participants receive Lantus®. 100 units insulin Glargine (equivalent to 3.64mg). Each pen consist of 3mls of solution (equivalent to 300units)

Both insulins dosages are titrated to fasting glucose aiming for a target range of 4-8mmol/l.

Original interventions:
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

01/09/2005

Overall trial end date

12/01/2017

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

21/04/2008

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Trial participating centre

Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Royal Bolton Hospital
Minerva Road
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Elsie Bertram Diabetes Centre
Norfolk and Norwich University Hospital Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Kingsmill Hospital
Mansfield Road Sutton in Ashfield
Nottingham
NG17 7AE
United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

Diabetes Centre
Ipswich Hospital NHS Trust Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Torbay Hospital
Lawes Bridge
Torbay
TQ2 7AA
United Kingdom

Trial participating centre

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

West Suffolk Hospital
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Trial participating centre

Medicine Guy Hilton Research Centre
Thornburrow Drive Hartshill
Stoke-on-Trent
ST4 7QB
United Kingdom

Trial participating centre

Hull Royal infirmary
Craven Building Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Trial participating centre

Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Leighton Hospital
Middlewich Road
Crewe
CW1 4QJ
United Kingdom

Trial participating centre

Queen’s Hospital
Belvedere Road
Burton upon Trent
DE13 0RB
United Kingdom

Trial participating centre

Peterborough City Hospital
Edith Cavell Campus Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Newham University Hospital
Glen Road Plaistow
London
E13 8SL
United Kingdom

Trial participating centre

Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
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
+44 1223 348490
research@addenbrookes.nhs.uk

Sponsor type

Not defined

Website

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

Funders

Funder type

Industry

Funder name

Novo Nordisk Pharmaceuticals Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

22/05/2017: The interventions section has been updated and the plain English summary has been added. 15/05/2017: The following updates have been made to the trial record: 1. The overall trial dates have been updated from 01/04/2008 - 30/06/2011 to 01/09/2005 - 12/01/2017 2. The recruitment dates have been updated from 01/04/2008 - 30/06/2011 to 21/04/2008 - 31/12/2016 3. The IPD sharing plan and publication and dissemination plan have been added 4. The participant information sheets have been uploaded 5. The trial participating centres have been added 11/05/2017: No publications found in PubMed, verifying study status with principal investigator