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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01123980
First received: May 13, 2010
Last updated: October 22, 2014
Last verified: October 2014
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: October 22, 2014
Health Authority: China: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 25, 2014