Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Official Title
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Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Faster-acting insulin aspart
* Drug: insulin detemir
* Drug: insulin aspart
* Drug: Faster-acting insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal time FIAsp and insulin detemir<br> | Drug: Faster-acting insulin aspart<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.<br>Drug: insulin detemir<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.<br>|
| Active Comparator: Meal time insulin aspart and insulin detemir<br> | Drug: insulin detemir<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.<br>Drug: insulin aspart<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted.<br>|
| Experimental: Post meal FIAsp and insulin detemir<br> | Drug: insulin detemir<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.<br>Drug: Faster-acting insulin aspart<br>* Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Change from baseline in HbA1c after 26 weeks of randomised treatment. | Week 0, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) | Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test). | Week 0, week 26 | 
| Change From Baseline in HbA1c (Post Meal Arm) | Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment. | Week 0, week 26 | 
| Number of Treatment Emergent Confirmed Hypoglycaemic Episodes | Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. | From baseline until week 26 | 
| Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of randomised treatment. | Week 0, week 26 | 
| Frequency of Adverse Events | All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment. | After 52 weeks of randomised treatment | 
| Change in HbA1c | Change from baseline in HbA1c (%) after 52 weeks of randomised treatment. | Week 0, week 52 | 
| Change in PPG (Postprandial Glucose) | Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment. | Week 0, week 52 |