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 (EasyMix)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01123980

JapicCTI-101139 (Other Identifier)

U1111-1114-4112 (Other Identifier)

BIASP-3756

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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521 participants in 2 patient groups

BIAsp 30

Experimental group

Description:

0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride

Treatment:

Drug: biphasic insulin aspart 30

Drug: glimepiride

Drug: metformin

Insulin glargine

Active Comparator group

Description:

0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride

Treatment:

Drug: insulin glargine

Drug: glimepiride

Drug: metformin