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
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
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