Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Study Overview
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Brief Summary
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This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes. The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Official Title
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A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg<br> | Drug: insulin degludec<br>* Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.<br>|
| Experimental: IGlar<br> | Drug: insulin glargine<br>* Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration |  | Within 0-46 hours after last trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose |  | Within 0-46 hours after last trial product administration | 
| Time from start of hypoglycaemic induction until each level of plasma glucose is reached |  | Within 0-46 hours after last trial product administration | 
| Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L |  | Within 0-46 hours after last trial product administration | 
| Hypoglycaemic symptoms score during recovery from hypoglycaemia |  | Within 0-46 hours after last trial product administration |