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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 (onset® 1)

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ClinicalTrials.gov Identifier: NCT01831765
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : January 23, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster-acting insulin aspart Drug: insulin detemir Drug: insulin aspart Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Actual Study Start Date : August 31, 2013
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Meal time FIAsp and insulin detemir Drug: Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Active Comparator: Meal time insulin aspart and insulin detemir Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Drug: insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
Experimental: Post meal FIAsp and insulin detemir Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Drug: Faster-acting insulin aspart
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831765


  Show 189 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01831765     History of Changes
Other Study ID Numbers: NN1218-3852
2010-024049-53 ( EudraCT Number )
U1111-1118-2442 ( Other Identifier: WHO )
First Posted: April 15, 2013    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: April 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs