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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Glimepiride; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Metformin

Criteria

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)