The effects of subcutaneous insulin detemir on glucose flux, pharmacokinetics and brain function in type one diabetes - The effects of insulin detemir in type 1 diabetes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001642-14-GB

Enrollment

Registered

2011-04-27

Start date

2011-07-11

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes mellitus

Interventions

Trade Name: Insulin detemir Product Name: Detemir (Levemir®) Product Code: EU/1/04/278/005 Pharmaceutical Form: Solution for injection Trade Name: Human insulin NPH insulatard Product Name: NPH insul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any trial-related activities. 2. Type 1 diabetes according to clinical judgement. 3. Duration of Type 1 diabetes greater than 12 months. 4. Current treatment basal bolus or biphasic insulin regimes. 5. Age greater than 18 years. 6. BMI of less than 35. 7. HbA1c of greater or equal to 5.5% and less than 9%. 8. Able and willing to complete the trial Are the trial subjects under 18? no 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

Exclusion criteria: 1. Proliferative retinopathy that has required acute treatment within last three months. 2. Impaired hepatic or renal function as judged by the investigator. 3. Cardiac problems as judged by the investigator. 4. Uncontrolled hypertension. ( BP greater than 160/90) 5. Mental incapacity. 6. Pregnancy. 7. Known or suspected allergy to trial products. 8. Any other condition that the investigator feels would interfere with the trial participation.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the glucose lowering effects of two commercially available insulins commonly used for the treatment of type 1 diabetes (insulin detemir and human insulin - NPH).;Secondary Objective: To investigate if there is any change in the following while patients are using the different insulin treatments 1. Fuel production 2. Brain function.;Primary end point(s): To compare the glucose lowering effects of two commercially available insulins which are commonly used for the treatment of type 1 diabetes (insulin detemir and human insulin - NPH).	—

Measure

Time frame

Main Objective: To compare the glucose lowering effects of two commercially available insulins commonly used for the treatment of type 1 diabetes (insulin detemir and human insulin - NPH).;Secondary Objective: To investigate if there is any change in the following while patients are using the different insulin treatments 1. Fuel production 2. Brain function.;Primary end point(s): To compare the glucose lowering effects of two commercially available insulins which are commonly used for the treatment of type 1 diabetes (insulin detemir and human insulin - NPH).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026