Determir versus Glargine for weight gain in adolescents with type 1 diabetes

ISRCTN ISRCTN49492872
DOI https://doi.org/10.1186/ISRCTN49492872
EudraCT/CTIS number 2007-004144-74
Secondary identifying numbers 4903
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
20/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Contact information

Ms Diane Picton
Scientific

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

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

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN49492872_PIS_12Jan13_V8_parents.pdf
Scientific titleA 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
Study acronymDETEMIR GLARGINE
Study hypothesisThe 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(s)Oxfordshire REC A, 26/10/2008, ref: 07/H0604/122
ConditionTopic: Medicines for Children Research Network, Diabetes Research Network; Subtopic: Type 1, All Diagnoses; Disease: All Diseases, Insulin switch, Metabolic, Paediatric
InterventionInterventions 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Determir, glargine
Primary outcome measureReduced weight gain. Full body dual energy x-ray absorptiometry (DEXA) will be done at baseline and 1 year.
Secondary outcome measuresTo 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 study start date01/09/2005
Overall study end date12/01/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsPlanned sample size: 112; UK sample size: 112
Total final enrolment97
Participant inclusion criteria1. 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 exclusion criteria1. 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 date21/04/2008
Recruitment end date31/12/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Royal Bolton Hospital
Minerva Road
Bolton
BL4 0JR
United Kingdom
Stepping Hill Hospital
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Elsie Bertram Diabetes Centre
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Kingsmill Hospital
Mansfield Road
Sutton in Ashfield
Nottingham
NG17 7AE
United Kingdom
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Diabetes Centre
Ipswich Hospital NHS Trust
Heath Road
Ipswich
IP4 5PD
United Kingdom
Torbay Hospital
Lawes Bridge
Torbay
TQ2 7AA
United Kingdom
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
West Suffolk Hospital
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom
Medicine Guy Hilton Research Centre
Thornburrow Drive
Hartshill
Stoke-on-Trent
ST4 7QB
United Kingdom
Hull Royal infirmary
Craven Building
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom
Leicester Royal Infirmary
Infirmary square
Leicester
LE1 5WW
United Kingdom
Leighton Hospital
Middlewich Road
Crewe
CW1 4QJ
United Kingdom
Queen’s Hospital
Belvedere Road
Burton upon Trent
DE13 0RB
United Kingdom
Peterborough City Hospital
Edith Cavell Campus
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
Newham University Hospital
Glen Road
Plaistow
London
E13 8SL
United Kingdom
Macclesfield District General Hospital
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Not defined

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

Phone +44 1223 348490
Email research@addenbrookes.nhs.uk
Website http://www.cuh.org.uk/research/research_index.html
ROR logo "ROR" https://ror.org/04v54gj93

Funders

Funder type

Industry

Novo Nordisk Pharmaceuticals Limited

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V8 12/01/2013 15/05/2017 No Yes
Participant information sheet version V8 12/01/2013 15/05/2017 No Yes
Participant information sheet version V8 12/01/2013 15/05/2017 No Yes
Basic results 20/05/2019 No No

Additional files

ISRCTN49492872_PIS_12Jan13_V8_parents.pdf
Uploaded 15/05/2017
ISRCTN49492872_PIS_12Jan13_V8_15yr+.pdf
Uploaded 15/05/2017
ISRCTN49492872_PIS_12Jan13_V8_13-15yr.pdf
Uploaded 15/05/2017

Editorial Notes

20/05/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
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