Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01697631

BIASP-1409

Details and patient eligibility

About

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
• HbA1c (glycosylated haemoglobin) equal to or below 12%
• Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion criteria

• History of drug or alcohol dependence
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
• Previous participation in this trial
• Receipt of any investigational drug within the last month prior to this trial
• Known or suspected allergy to trial products or related products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

BIAsp

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Insulin aspart

Experimental group

Treatment:

Drug: insulin aspart

Drug: biphasic insulin aspart 30