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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin aspart

Drug: insulin degludec

Drug: insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00982228

2008-005774-13 (EudraCT Number)

U1111-1116-1578 (Other Identifier)

U1111-1111-8789 (Other Identifier)

2009-015755-24 (EudraCT Number)

NN1250-3583

Details and patient eligibility

About

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.

The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.

Enrollment

629 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%
BMI (Body Mass Index) below or equal to 35.0 kg/m^2
For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)

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 according to local requirements
Cancer and medical history of cancer