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Completed

NCT Number: NCT01123980

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

biphasic insulin aspart 30

Drug

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

metformin

Drug

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

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

Glimepiride

Drug

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

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

insulin glargine

Drug

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

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Time frame: Week 0, week 24

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. Number of Hypoglycaemic Episodes - All

    Time frame: Weeks 0-24

  5. 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.

  6. 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)).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: EasyMix

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 14, 2010
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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