A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01835431
First received: April 16, 2013
Last updated: November 13, 2014
Last verified: November 2014
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Purpose
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals in children and adolescents with type 1 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin degludec/insulin aspart Drug: insulin aspart Drug: insulin detemir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus |
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 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]
- Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
- Number of treatment emergent confirmed hypoglycaemic episodes (plasma glucose (PG) below 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia) [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
- Number of treatment emergent nocturnal confirmed hypoglycaemic episodes [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
- Number of hyperglycaemic episodes (PG above 14.0 mmol/L (250 mg/dL) where subject looks/feels ill [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
- Number of hyperglycaemic episodes (PG above 14.0 mmol/L (250 mg/dL) where subject looks/feels ill with ketosis (blood ketones above 1.5 mmol/L) [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 362 |
| Study Start Date: | October 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Insulin degludec/insulin aspart |
Drug: insulin degludec/insulin aspart
Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.
Drug: insulin aspart
Administered s.c. with the remaining meals. Dose individually adjusted.
|
| Active Comparator: Insulin detemir |
Drug: insulin detemir
Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.
Drug: insulin aspart
Administered s.c. at meal-times. Dose individually adjusted.
|
Eligibility| Ages Eligible for Study: | 1 Year to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Subjects diagnosed with type 1 diabetes mellitus
- HbA1c below or equal to 11.0%
Exclusion Criteria:
- Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator
- More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening)
- Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
Contacts and Locations
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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: NCT01835431
Show 35 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835431
Show 35 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: | NCT01835431 History of Changes |
| Other Study ID Numbers: | NN5401-3816, 2012-003566-41, U1111-1133-0958, PIP no. be confirmed |
| Study First Received: | April 16, 2013 |
| Last Updated: | November 13, 2014 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: Ministry of Health Canada: Health Canada Czech Republic: State Institute for Drug Control Croatia: Ministry of Health and Social Care Israel: Ministry of Health Macedonia, The Former Yugoslav Republic of: Ministry of Health Poland: Ministry of Health Russia: Ministry of Health of the Russian Federation Serbia: Agency for Drugs and Medicinal Devices Slovenia: Agency for Medicinal Products - Ministry of Health South Africa: Medicines Control Council Spain: Ministry of Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases |
Insulin Insulin Aspart Insulin, Globin Zinc Insulin, Long-Acting Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 02, 2015