Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes (BEGIN™)

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec
Drug: insulin aspart
Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00972283
U1111-1111-8648 (Other Identifier)
2009-015816-17 (EudraCT Number)
U1111-1114-9067 (Other Identifier)
NN1250-3582
2008-005777-35 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.

Enrollment

1,006 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For MAIN period (NN1250-3582):

  • Type 2 diabetes mellitus for at least 6 months
  • Ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (OAD) prior to trial start
  • HbA1c 7.0-10.0 % (both inclusive)
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2

For EXTENSION period (NN1250-3667):

  • Completion of the 52 week treatment period in NN1250-3582

Exclusion criteria

For MAIN period (NN1250-3582):

  • Treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • 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)

1,006 participants in 2 patient groups

IDeg OD
Experimental group
Treatment:
Drug: insulin aspart
Drug: insulin degludec
IGlar OD
Active Comparator group
Treatment:
Drug: insulin aspart
Drug: insulin glargine

Trial contacts and locations

136

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Data sourced from clinicaltrials.gov

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