Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669864

BIASP-1960

Details and patient eligibility

About

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Enrollment: 293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
• HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
• BMI (Body Mass Index) maximum 40 kg/m2

Exclusion criteria

• Metformin contraindications according to local practice
• Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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293 participants in 1 patient group

BIAsp 30-30

Experimental group

Description:

Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Treatment:

Drug: biphasic insulin aspart 30

Drug: metformin