A comparison of the effects of insulin Detemir with insulin Glargine on weight gain in female adolescents and young adults with Type 1 Diabetes (T1D) on a basal bolus regime - A comparison of Insulins Detemir and Glargine in Girls with Diabetes

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

• Registration Number: EUCTR2007-004144-74-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-15
• Study Completion: 2017-01-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

Type 1 diabetes, diagnosed over 1 year, or C-peptide negative

Postmenarchal OR in late puberty (Tanner breast stage 4 or 5)

HbA1c <12%

BMI-SDS less than or equal to +2.5 for age

No active or untreated concurrent disease

Written informed, witnessed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Non-type 1 diabetes mellitus including those secondary to an existing pathology.

Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results.

Pregnant or breast feeding women

Females of reproductive age who are unwilling to take appropriate measures of contraception

Patients taking medication likely to affect glucose metbolism eg metformin or oral corticosteroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does using Insulin Detemir in comparison to insulin Glargine result in less weight gain in young women with Type 1 diabetes?;Primary end point(s): BMI standard deviation score after 1 year;<br> Secondary Objective: Does using Insulin Detemir in comaprison to insulin Glargine in these patients result in:<br><br> 1. Differences in body fat<br> 2. Different control of blood glucose levels and rates of hypoglycaemia (low blood sugar)<br> 3. Differences in the amounts of other hormones (androgens or male sex hormones)<br> 4. Differences in the effects of growth hormone<br>