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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123980
First Posted: May 14, 2010
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 24 ]

Secondary Outcome Measures:
  • 9-point Plasma Glucose Profiles [ Time Frame: 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 7.0% [ Time Frame: Week 24 ]
    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 ]
    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 ]
  • Number of Hypoglycaemic Episodes - Severe and Minor [ Time Frame: 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 [ Time Frame: Weeks 0-24 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123980


  Show 34 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01123980     History of Changes
Other Study ID Numbers: BIASP-3756
U1111-1114-4112 ( Other Identifier: WHO )
JapicCTI-101139 ( Other Identifier: JAPIC )
First Submitted: May 13, 2010
First Posted: May 14, 2010
Results First Submitted: June 1, 2012
Results First Posted: July 9, 2012
Last Update Posted: February 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Glimepiride
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors