Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.

Official Title
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A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin NPH
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Fasting c-peptide below lower limit of normal fasting range Duration of type 1 diabetes for at least 12 months Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections HbA1c maximum 9.0% (using Biorad Variant method) Able and willing to perform self-monitoring of blood glucose Basal insulin requirement at least 30% of the total daily insulin dose BMI (body Mass Index) maximum 35 kg/m^2 Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Total daily insulin dose above 1.4 IU/kg/day Known unawareness of hypoglycaemia Impaired hepatic function Impaired renal function Cardiac problems Uncontrolled, treated/untreated hypertension Known or suspected allergy to trial product or related products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Detemir<br> | Drug: insulin detemir<br>* Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2<br>Drug: insulin aspart<br>* Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2<br>|
| Active Comparator: NPH<br> | Drug: insulin NPH<br>* Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2<br>Drug: insulin aspart<br>* Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of total self-recorded hypoglycaemic episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of total major hypoglycaemic episodes |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  | 
| 8-point plasma glucose profiles |  |  | 
| Serum glucose profiles |  |  | 
| 72-hours glucose profile |  |  | 
| Within-subject variation in home-measured fasting plasma glucose |  |  | 
| Incidence of adverse events |  |  |