Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612040

NN1250-1835

2007-002474-60 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Enrollment: 178 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes for at least one year
• HbA1c 7-11% (both inclusive)
• Treated with insulin for at least six months - any regimen

Exclusion criteria

• Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
• Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 3 patient groups

SIBA (D)

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin aspart

SIBA (E)

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin aspart

IGlar

Experimental group

Treatment:

Drug: insulin glargine

Drug: insulin aspart