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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00669864

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

NCT00807092

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

NCT00627445

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes

NCT01427920

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus

NCT01892020

Diabetes Diabetes Mellitus, Type 2

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIAsp 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

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

metformin

Intervention Type DRUG

China: Tablets, 500 mg. Min. 1500 mg/day.

Japan: Tablets, 250 mg. Min 500 mg/day.

glimepiride

Intervention Type DRUG

China: Tablets, 2 mg. Min. 4 mg/day.

Japan: Tablets, 1 mg. Min. 4 mg/day.

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

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

China: Tablets, 500 mg. Min. 1500 mg/day.

Japan: Tablets, 250 mg. Min 500 mg/day.

glimepiride

Intervention Type DRUG

China: Tablets, 2 mg. Min. 4 mg/day.

Japan: Tablets, 1 mg. Min. 4 mg/day.

insulin glargine

Intervention Type DRUG

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biphasic insulin aspart 30

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Intervention Type DRUG

metformin

China: Tablets, 500 mg. Min. 1500 mg/day.

Japan: Tablets, 250 mg. Min 500 mg/day.

Intervention Type DRUG

glimepiride

China: Tablets, 2 mg. Min. 4 mg/day.

Japan: Tablets, 1 mg. Min. 4 mg/day.

Intervention Type DRUG

insulin glargine

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.