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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin glargine; Drug: insulin degludec; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079234

U1111-1112-8813 (Other Identifier)

NN1250-3770

2009-012923-27 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Enrollment: 493 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
• Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
• HbA1c maximum 10.0 % by central laboratory analysis
• Body Mass Index (BMI) below or equal to 35.0 kg/m^2
• Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
• Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

Exclusion criteria

• Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
• Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
• Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

493 participants in 3 patient groups

Flex + insulin aspart

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

Fixed + insulin aspart

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin degludec

IGlar + insulin aspart

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin glargine