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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: metformin; Drug: glimepiride; Drug: insulin glargine

• Registration Number: NCT01123980
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-06-01
• Results First Submitted QC: 2012-06-01
• Results First Posted: 2012-07-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 521

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIAsp 30	glimepiride	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
Insulin glargine	insulin glargine	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
BIAsp 30	biphasic insulin aspart 30	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
Insulin glargine	metformin	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
BIAsp 30	metformin	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
Insulin glargine	glimepiride	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

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c)	Week 0, week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving HbA1c Below 7.0%	Week 24	The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment
9-point Plasma Glucose Profiles	Week 24	Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%	Week 24	The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment
Number of Hypoglycaemic Episodes - All	Weeks 0-24
Number of Hypoglycaemic Episodes - Severe and Minor	Weeks 0-24	Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.
Number of Hypoglycaemic Episodes	Weeks 0-24	All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Yokohama-shi, Japan