Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30; Drug: metformin; Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627445

BIASP-1858

Details and patient eligibility

About

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Enrollment: 441 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
• HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
• FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
• BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Exclusion criteria

• Metformin contraindications according to local practice
• Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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441 participants in 2 patient groups

BIAsp 50-50-30

Experimental group

Description:

Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin

Treatment:

Drug: metformin

Drug: biphasic insulin aspart 50

Drug: biphasic insulin aspart 30

BIAsp 30-30

Active Comparator group

Description:

Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

Treatment:

Drug: metformin

Drug: biphasic insulin aspart 30