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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01831765
First Posted: April 15, 2013
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: Faster-acting insulin aspart Drug: insulin detemir Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: 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

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 ]

Secondary Outcome Measures:
  • Change from baseline in 2-hour PPG (Postprandial glucose) increment (meal test) [ Time Frame: Week 0, week 26 ]
  • Change from baseline in HbA1c (post meal arm) [ Time Frame: Week 0, week 26 ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From baseline until week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]
  • Frequency of adverse events [ Time Frame: After 52 weeks of randomised treatment ]
  • Change in HbA1c [ Time Frame: Week 0, week 52 ]
  • Change in PPG (postprandial glucose) [ Time Frame: Week 0, week 52 ]

Enrollment: 1290
Actual Study Start Date: August 31, 2013
Study Completion Date: June 30, 2015
Primary Completion Date: June 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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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
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
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 Submitted: April 11, 2013
First Posted: April 15, 2013
Last Update Posted: April 4, 2017
Last Verified: March 2017

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