Type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Trade Name: Levemir Flexpen
Pharmaceutical Form: Injection*
Trade Name: Lantus 100 U/ml OptiSet solution for injection
Pharmaceutical Form: Injection*
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; Secondary Objective: Does using Insulin Detemir in comaprison to insulin Glargine in these patients result in: 1. Differences in body fat 2. Different control of blood glucose levels and rates of hypoglycaemia (low blood sugar) 3. Differences in the amounts of other hormones (androgens or male sex hormones) 4. Differences in the effects of growth hormone | — |
Countries
United Kingdom
Outcome results
None listed