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

Phase 3

Completed

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

• Registration Number: ISRCTN49492872
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Study Completion: 2017-01-12
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 97

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduced weight gain. Full body dual energy x-ray absorptiometry (DEXA) will be done at baseline and 1 year.

Secondary Outcome Measures

Name	Time	Method
<br> To explore differences between the two insulins on the following:<br> 1. HBa1c<br> 2. Fat mass<br><br> Study bloods will be taken at baseline, 6 and 12 months.<br>