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

Plain English summary of protocol

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

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

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"	https://ror.org/04v54gj93

Funders

Funder type

Industry

Results and Publications

Study outputs

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