Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 70; Drug: biphasic human insulin 30; Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526980

BIASP-1319

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Type 2 diabetes
• Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months
• HbA1c maximum 10.0%
• BMI (Body Mass Index) maximum 35.0 kg/m2
• Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion criteria

• The receipt of any investigational drug within the last 30 days prior to this trial
• Total daily insulin dose minimum 2.0 U/(kg·day)
• A history of drug abuse or alcohol dependence within the last 5 years
• Impaired hepatic function
• Impaired renal function
• Cardiac disease
• Severe, uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70

Drug: biphasic human insulin 30

Treatment period 2

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 70

Drug: biphasic human insulin 30