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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart 30 Drug: metformin Drug: glimepiride Drug: insulin glargine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Insulin human Glimepiride Insulin aspart Insulin glargine

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

9-point Plasma Glucose Profiles [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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 7.0% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment
Number of Hypoglycaemic Episodes - All [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
Number of Hypoglycaemic Episodes - Severe and Minor [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
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 [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).

Enrollment:	521
Study Start Date:	May 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Drug: biphasic insulin aspart 30 Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily. Drug: metformin China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day. Drug: glimepiride China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day.
Active Comparator: 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	Drug: metformin China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day. Drug: glimepiride China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day. Drug: insulin glargine Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123980

Locations

China, Beijing

Beijing, Beijing, China, 100029
Japan

Higashi-ku, Japan, 812 8582

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Louise Kvistgaard

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01123980 History of Changes
Other Study ID Numbers:	BIASP-3756, U1111-1114-4112, JapicCTI-101139
Study First Received:	May 13, 2010
Results First Received:	June 1, 2012
Last Updated:	July 19, 2012
Health Authority:	China: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin aspart
Glargine
Insulin
Metformin

Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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)