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Insulin

Insulin Detemir +Insulin Aspart for Type 1 Diabetes (BEGIN™ Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 26 weeks and 52 weeks of treatment
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Type 1 Diabetes
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 26 weeks and 52 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 26 weeks and 52 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)
Secondary study objectives
Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)
Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)
Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)
+6 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Insulin Detemir +Insulin AspartExperimental Treatment2 Interventions
Group II: Insulin Degludec + Insulin AspartExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin degludec
FDA approved
Insulin aspart
FDA approved
Insulin detemir
FDA approved

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,552 Previous Clinical Trials
2,444,685 Total Patients Enrolled
Global Clinical Registry (GCR, 1452)Study DirectorNovo Nordisk A/S
778 Previous Clinical Trials
767,096 Total Patients Enrolled
~25 spots leftby Nov 2025
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