A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus (BEGIN™)
This study is ongoing, but not recruiting participants.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01513473
First received: January 16, 2012
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Drug: insulin degludec 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: Open Label Primary Purpose: Treatment |
| Official Title: | A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in Children and Adolescents 1 to Less Than 18 Years With Type 1 Diabetes Mellitus on a Basal-bolus Regimen With Insulin Aspart as Bolus Insulin, Followed by a 26-week Extension Investigating Long Term Safety (BEGIN™: Young 1) |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change from baseline in HbA1c (glycosylated haemoglobin) (%) at 26 weeks (analysed by central laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in HbA1c (%) at 52 weeks (analysed by central laboratory) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
- Change from baseline in fasting blood glucose (FPG) at 26 weeks (analysed by central laboratory) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
- Change from baseline in fasting blood glucose (FPG) at 52 weeks (analysed by central laboratory) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
- Number of treatment emergent adverse events (TEAEs) [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
- Number of hypoglycaemic episodes [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
- Number of self-measured hyperglycaemia (episodes of PG above 11.1 mmol/L (200 mg/dL)) [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
- Number of episodes with self monitored blood ketones above 1.5 mmol (capillary blood ketone measurement to be performed if self-measured plasma glucose (SMPG) exceeds 14.0 mmol/l (250 mg/dL)) [ Time Frame: After 26 weeks and 52 weeks of treatment ] [ Designated as safety issue: No ]
- Steady-state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the first 26 weeks of treatment [ Time Frame: Between week 1 and week 26 ] [ Designated as safety issue: No ]
- Insulin antibodies (insulin degludec specific, insulin detemir specific, insulin aspart specific and antibodies cross-reacting to human insulin) [ Time Frame: After 52 weeks of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 346 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: insulin degludec + insulin aspart |
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
|
| Active Comparator: insulin detemir + insulin aspart |
Drug: insulin detemir
Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
Drug: insulin aspart
Injected subcutaneously (under the skin) as mealtime bolus insulin. 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, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
- Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
- Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
- HbA1c (glycosylated haemoglobin) maximum 11%
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product(s) or related products
- Previous participation in this trial. Participation is defined as randomisation
- Girls who are pregnant, breastfeeding or intend to become pregnant
- Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
- Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
- More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
- Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
- The receipt of any investigational drug within 1 month prior to Visit 1
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513473
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Hide Study LocationsLocations
| United States, Arkansas | |
| Novo Nordisk Clinical Trial Call Center | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| Novo Nordisk Clinical Trial Call Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Novo Nordisk Clinical Trial Call Center | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Gainesville, Florida, United States, 32608 | |
| Novo Nordisk Clinical Trial Call Center | |
| Jacksonville, Florida, United States, 32207-8426 | |
| Novo Nordisk Clinical Trial Call Center | |
| Melbourne, Florida, United States, 32901 | |
| Novo Nordisk Clinical Trial Call Center | |
| Orlando, Florida, United States, 32806 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Novo Nordisk Clinical Trial Call Center | |
| Atlanta, Georgia, United States, 30322 | |
| Novo Nordisk Clinical Trial Call Center | |
| Atlanta, Georgia, United States, 30318 | |
| Novo Nordisk Clinical Trial Call Center | |
| Atlanta, Georgia, United States, 30339 | |
| United States, Kentucky | |
| Novo Nordisk Clinical Trial Call Center | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Maryland | |
| Novo Nordisk Clinical Trial Call Center | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Massachusetts | |
| Novo Nordisk Clinical Trial Call Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| Buffalo, New York, United States, 14222 | |
| United States, Ohio | |
| Novo Nordisk Clinical Trial Call Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Novo Nordisk Clinical Trial Call Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Novo Nordisk Clinical Trial Call Center | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Dallas, Texas, United States, 75390-8527 | |
| Novo Nordisk Clinical Trial Call Center | |
| Dallas, Texas, United States, 75235 | |
| United States, Virginia | |
| Novo Nordisk Clinical Trial Call Center | |
| Norfolk, Virginia, United States, 23507 | |
| Bulgaria | |
| Varna, Bulgaria, 9010 | |
| Finland | |
| Espoo, Finland, 02740 | |
| France | |
| Toulouse, France, 31059 | |
| Germany | |
| Hannover, Germany, 30173 | |
| Italy | |
| Chieti, Italy, 66100 | |
| Japan | |
| Tokyo, Japan, 157 8535 | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Netherlands | |
| Amersfoort, Netherlands, 3816 CP | |
| Russian Federation | |
| Moscow, Russian Federation, 117036 | |
| South Africa | |
| Cape Town, Western Cape, South Africa, 7925 | |
| United Kingdom | |
| Manchester, United Kingdom, M13 9WL | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Malene Bording Krüger | Novo Nordisk |
| Study Director: | Trine Stougaard | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01513473 History of Changes |
| Other Study ID Numbers: | NN1250-3561, 2011-003148-39, P/44/2010, U1111-1122-4758 |
| Study First Received: | January 16, 2012 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Food and Drug Administration Russia: Federal Service for Control of Health Care and Social Development Japan: Ministry of Health, Labor and Welfare South Africa: Medicines Control Council Italy: The Italian Medicines Agency Macedonia, The Former Yugoslav Republic of: Ministry of Health of Republic of Macedonia Bulgaria: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: Dutch Health Care Inspectorate Finland: Finnish Medicines Agency Fimea France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin aspart Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013