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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01831765
First received: April 11, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin aspart (FIAsp)
Drug: insulin detemir
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 2-hour PPG (Postprandial glucose) increment (meal test) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c (post meal arm) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From baseline until week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: After 52 weeks of randomised treatment ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial glucose) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1095
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meal time FIAsp and insulin detemir Drug: insulin aspart (FIAsp)
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: insulin aspart (FIAsp)
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal dosing is defined as injecting 20 minutes after the start of the meal.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831765

  Show 103 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01831765     History of Changes
Other Study ID Numbers: NN1218-3852, U1111-1118-2442, 2010-024049-53
Study First Received: April 11, 2013
Last Updated: August 12, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014