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OpenTrials
Completed

NCT Number: NCT01831765

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faster-acting insulin aspart

Drug

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.

insulin detemir

Drug

Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.

insulin aspart

Drug

Injected subcutaneously (s.c., under the skin), dose individually adjusted.

Primary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Time frame: Week 0, week 26

    Change from baseline in HbA1c after 26 weeks of randomised treatment.

Secondary outcomes

  1. Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)

    Time frame: Week 0, week 26

    Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).

  2. Change From Baseline in HbA1c (Post Meal Arm)

    Time frame: Week 0, week 26

    Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.

  3. Number of Treatment Emergent Confirmed Hypoglycaemic Episodes

    Time frame: From baseline until week 26

    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.

  4. Change From Baseline in Body Weight

    Time frame: Week 0, week 26

    Change from baseline in body weight after 26 weeks of randomised treatment.

  5. Frequency of Adverse Events

    Time frame: After 52 weeks of randomised treatment

    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.

  6. Change in HbA1c

    Time frame: Week 0, week 52

    Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.

  7. Change in PPG (Postprandial Glucose)

    Time frame: Week 0, week 52

    Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: onset® 1

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2013
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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