NCT01513473 (BEGIN™) is a Phase 3 clinical trial of insulin degludec in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT01513473?

NCT01513473 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT01513473?

Interventions in NCT01513473: insulin degludec, insulin detemir, insulin aspart.

What condition does NCT01513473 study?

NCT01513473 studies Diabetes, Diabetes Mellitus, Type 1.

Is NCT01513473 still recruiting?

NCT01513473 is currently completed. Last updated 13 June 2019.

Are results published for NCT01513473?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-06-13 · How we verify

NCT01513473: BEGIN™

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

Completed Phase 3 Results posted Last updated 13 June 2019

What this trial tests

Phase 3 trial testing insulin degludec in Diabetes in 350 participants. Completed in 30 July 2013.

Timeline

16 January 2012

Primary endpoint
30 July 2013

30 July 2013

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	350
Start date	16 January 2012
Primary completion	30 July 2013
Estimated completion	30 July 2013
Sites	81 locations across France, Italy, Finland, Japan, Netherlands, Russia, South Africa, United Kingdom

Drugs / interventions tested

insulin degludec (INSULIN DEGLUDEC) — full drug profile →
insulin detemir (INSULIN DETEMIR) — full drug profile →
insulin aspart (INSULIN ASPART) — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 1 to 17, any sex, with Diabetes or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory) Primary · Week 0, week 26

Change from baseline in HbA1c (%) after 26 weeks of treatment.

Group	Value	95% CI
IDeg + IAsp	-0.20	± 0.95
IDet + IAsp	-0.31	± 0.89

Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory) Secondary · Week 0, week 52

Change from baseline in HbA1c (%) after 52 weeks of treatments.

Group	Value	95% CI
IDeg + IAsp	-0.27	± 1.07
IDet + IAsp	-0.22	± 1.03

Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory) Secondary · Week 0, week 26

Change from baseline in FPG after 26 weeks of treatment.

Group	Value	95% CI
IDeg + IAsp	-0.67	± 5.99
IDet + IAsp	0.50	± 8.37

Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory) Secondary · Week 0, week 52

Change from baseline in FPG after 52 weeks of treatment.

Group	Value	95% CI
IDeg + IAsp	-1.29	± 6.53
IDet + IAsp	1.10	± 8.24

Number of Treatment Emergent Adverse Events (TEAEs) Secondary · After 26 weeks and 52 weeks of treatment

TEAE is defined as an event that has 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.

TEAEs -26 weeks

Group	Value	95% CI
IDeg + IAsp	810
IDet + IAsp	761

TEAEs -52 weeks

Group	Value	95% CI
IDeg + IAsp	1462
IDet + IAsp	1266

Number of Hypoglycaemic Episodes Secondary · After 26 weeks and 52 weeks of treatment

Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal \[11 p.m. - 7 a.m./23:00 - 07:00\] and over the entire day (24 hours)

26 weeks (entire day)

Group	Value	95% CI
IDeg + IAsp	11712
IDet + IAsp	10991

26 weeks (nocturnal)

Group	Value	95% CI
IDeg + IAsp	1261
IDet + IAsp	1458

52 weeks (entire day)

Group	Value	95% CI
IDeg + IAsp	21560
IDet + IAsp	18373

52 weeks (nocturnal)

Group	Value	95% CI
IDeg + IAsp	2336
IDet + IAsp	2586

Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL)) Secondary · After 26 weeks and 52 weeks of treatment

Episodes of PG \>11.1mmol/L (200mg/dL)

26 weeks

Group	Value	95% CI
IDeg + IAsp	31264
IDet + IAsp	31173

52 weeks

Group	Value	95% CI
IDeg + IAsp	58679
IDet + IAsp	52831

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)) Secondary · After 26 weeks and 52 weeks of treatment

Blood ketones \> 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment

26 weeks

Group	Value	95% CI
IDeg + IAsp	44
IDet + IAsp	86

52 weeks

Group	Value	95% CI
IDeg + IAsp	109
IDet + IAsp	161

Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment Secondary · Between week 1 and week 26

Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.

week 2

Group	Value	95% CI
IDeg + IAsp	4540.4	± 3999.0
IDet + IAsp	3972.2	± 6721.8

week 12

Group	Value	95% CI
IDeg + IAsp	4148.1	± 3726.9
IDet + IAsp	5430.1	± 9067.7

week 26

Group	Value	95% CI
IDeg + IAsp	4105.6	± 3456.5
IDet + IAsp	6377.0	± 10930.6

Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin) Secondary · After 52 weeks of treatment

Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)

Insulin aspart specific antibodies

Group	Value	95% CI
IDeg + IAsp	1.1	± 2.6
IDet + IAsp	1.5	± 2.3

Insulin Detemir specific antibodies

Group	Value	95% CI
IDeg + IAsp	NA	± NA
IDet + IAsp	6.1	± 6.5

Insulin Degludec specific antibodies

Group	Value	95% CI
IDeg + IAsp	0	± 0.3
IDet + IAsp	NA	± NA

X-reacting AB Hu Insulin

Group	Value	95% CI
IDeg + IAsp	17.2	± 7.7
IDet + IAsp	26.0	± 19.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IDeg + IAsp

Serious: 18/174 (10%)

Deaths: —

IDet + IAsp

Serious: 16/175 (9%)

Deaths: —

Serious adverse events (25 terms)

Reaction	System	IDeg + IAsp	IDet + IAsp
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Hypoglycaemic seizure	Nervous system disorders	—	—
Appendicitis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Gastroenteritis viral	Infections and infestations	—	—
Blood ketone body increased	Investigations	—	—
Faecaloma	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Respiratory tract infection viral	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—
Toxicity to various agents	Injury, poisoning and procedural complications	—	—
Wrong drug administered	Injury, poisoning and procedural complications	—	—
Body temperature increased	Investigations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Ketosis	Metabolism and nutrition disorders	—	—
Convulsion	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Hypoglycaemic unconsciousness	Nervous system disorders	—	—
Loss of consciousness	Nervous system disorders	—	—
Anxiety disorder	Psychiatric disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (25 terms — click to expand)

Reaction	System	IDeg + IAsp	IDet + IAsp
Nasopharyngitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Blood ketone body increased	Investigations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Pyrexia	General disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Ear infection	Infections and infestations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Ear pain	Ear and labyrinth disorders	—	—
Gastroenteritis viral	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—

Most-reported serious reactions: Hypoglycaemia, Hypoglycaemic seizure, Appendicitis, Gastroenteritis, Gastroenteritis viral, Blood ketone body increased, Faecaloma, Vomiting.

Data from ClinicalTrials.gov NCT01513473 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes.
Thalange N, Deeb L, Iotova V, Kawamura T, et al · · 2015 · cited 46× · PMID 25683037 · DOI 10.1111/pedi.12263
(Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.
Hemmingsen B, Metzendorf MI, Richter B. · · 2021 · cited 18× · PMID 33662147 · DOI 10.1002/14651858.cd013498.pub2
The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials.
Thalange N, Deeb L, Klingensmith G, Franco DR, et al · · 2019 · cited 12× · PMID 30666772 · DOI 10.1111/pedi.12821
Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin.
Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, et al · · 2017 · cited 11× · PMID 28442823 · DOI 10.2337/cd15-0058
Ultra‐long acting insulin versus long‐acting insulin for type 1 diabetes mellitus
Ooi C, Ting T, Lye M. · · 2018

Verify or expand the search:

Other trials of insulin degludec

Trials testing the same drug.

NCT06767748 — A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated W · Phase 3 · active not recruiting
NCT05904743 — INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes · Phase 4 · completed
NCT05243628 — Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes · Phase 4 · completed
NCT04848480 — A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both · Phase 3 · completed
NCT04315688 — A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia · completed

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Currently open trials in the same condition.

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Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01513473 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 13 June 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01513473.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing