NCT01123980|CompletedPhase 4Results

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

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An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insulin Naive Subjects With Type 2 Diabetes

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3 other identifiers

BIASP-3756U1111-1114-4112JapicCTI-101139

Study Type

interventional

Target

521

Locations

2 countries

Sites

Timeline

RegisteredMay 2010

StartedMay 2010

CompletionJun 2011

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

521

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started May 2010

Geographic Reach

2 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 9, 2012

Completed

Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

May 13, 2010

Results QC Date

June 1, 2012

Last Update Submit

January 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

9-point Plasma Glucose Profiles
Week 24
Percentage of Subjects Achieving HbA1c Below 7.0%
Week 24
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Week 24
Number of Hypoglycaemic Episodes - All
Weeks 0-24
Number of Hypoglycaemic Episodes - Severe and Minor
Weeks 0-24
+1 more secondary outcomes

Study Arms (2)

BIAsp 30

EXPERIMENTAL

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

Drug: biphasic insulin aspart 30Drug: metforminDrug: glimepiride

Insulin glargine

ACTIVE COMPARATOR

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

Drug: metforminDrug: glimepirideDrug: insulin glargine

Interventions

biphasic insulin aspart 30DRUG

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

BIAsp 30

metforminDRUG

China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day.

BIAsp 30Insulin glargine

glimepirideDRUG

China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day.

BIAsp 30Insulin glargine

insulin glargineDRUG

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

Insulin glargine

Eligibility Criteria

Age20 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.