Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Novo Nordisk A/S521 enrolled

Overview

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before. The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

521

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months * Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months * Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months * Insulin naive * HbA1c between 7.0% and 10.0% * FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL) * Body Mass Index (BMI) below 40.0 kg/m\^2 Exclusion Criteria: * Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial * Any disease or condition which the Investigator feels would interfere with the trial * Any contraindication to metformin or glimepiride (according to local labelling)