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Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes (BEGIN™)

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: insulin aspart
Drug: insulin degludec
Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01074268
2009-011672-29 (EudraCT Number)
NN1250-3585
JapicCTI-101067 (Registry Identifier)
2009-015721-36 (EudraCT Number)
JapicCTI-22-0677 (Registry Identifier)
U1111-1111-7249 (Other Identifier)
U1111-1114-9479 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Enrollment

456 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 diabetes mellitus for at least 12 months
  • Current treatment with any basal bolus insulin for at least 12 months
  • HbA1c below or equal to 10.0%
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2
  • For Japan only: Minimum age is 20 years
  • For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)

Exclusion criteria

  • Use of any other antidiabetic drug than insulin within the last 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  • Cancer and medical history of cancer

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

456 participants in 2 patient groups

IDeg OD
Experimental group
Treatment:
Drug: insulin aspart
Drug: insulin degludec
IDet
Active Comparator group
Treatment:
Drug: insulin detemir
Drug: insulin aspart

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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