Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: metformin; Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00613951

2007-002462-35 (EudraCT Number)

NN5401-1792

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Enrollment: 182 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
• Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
• HbA1c, 7.0-11.0 % (both inclusive)
• Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)

Exclusion criteria

• Metformin contraindication according to local practice
• Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
• Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 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 (except for conditions associated with type 2 diabetes) 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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182 participants in 3 patient groups

SIAC 30 (B)

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: metformin

Drug: insulin degludec/insulin aspart

SIAC 45 (B)

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart

Drug: metformin

Drug: insulin degludec/insulin aspart

BIAsp 30

Active Comparator group

Treatment:

Drug: biphasic insulin aspart

Drug: metformin