Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic human insulin; Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467401

BIASP-1394

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.

Enrollment: 292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 24 months
• Insulin treatment for the pase 3 months
• HbA1c (glycosylated haemoglobin) below 13%
• BMI (Body Mass Index) below 40 kg/m^2
• Ability and willingness to perform self-blood glucose monitoring

Exclusion criteria

• Receipt of any investigational drug within 4 weeks prior to this trial
• Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
• Total daily insulin dosage less than or equal to 1.8 IU/kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: biphasic insulin aspart

B

Active Comparator group

Treatment:

Drug: biphasic human insulin