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DiabetesPhase 4EasyMixNCT01123980

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

A Phase 4 study testing biphasic insulin aspart 30, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
biphasic insulin aspart 30, metformin and glimepiride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
521 participants
Where
34 sitesin 2 countries
Study dates
May 2010to Jun 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

China21 sites

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100029

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100101

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100191

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100700

  • Novo Nordisk Investigational Site

    Beijing, Beijing Municipality, 100853

  • Novo Nordisk Investigational Site

    Chongqing, Chongqing Municipality, 400010

  • Novo Nordisk Investigational Site

    Dalian, Liaoning, 116011

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian, 350025

  • Novo Nordisk Investigational Site

    Harbin, Heilongjiang, 150001

  • Novo Nordisk Investigational Site

    Nanchang, Jiangxi, 330006

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu, 210012

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu, 210029

  • Novo Nordisk Investigational Site

    Shenyang, Liaoning, 110004

  • Novo Nordisk Investigational Site

    Shenyang, Liaoning, 110021

  • Novo Nordisk Investigational Site

    Shenyang, 110001

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin Municipality, 300052

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin Municipality, 300070

  • Novo Nordisk Investigational Site

    Tianjin, 300211

  • Novo Nordisk Investigational Site

    Wuxi, Jiangsu, 214023

  • Novo Nordisk Investigational Site

    Xi'an, Shaanxi, 710061

  • Novo Nordisk Investigational Site

    Zhengzhou, Henan, 450052

Other trials in China

Japan13 sites

  • Novo Nordisk Investigational Site

    Asahikawa-shi, Hokkaido, 078 8510

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0002

  • Novo Nordisk Investigational Site

    Gifu City, Gifu, 5008717

  • Novo Nordisk Investigational Site

    Higashiku, 812 8582

  • Novo Nordisk Investigational Site

    Kumamoto-shi,Kumamoto, 862 0976

  • Novo Nordisk Investigational Site

    Minatoku, 108 0073

  • Novo Nordisk Investigational Site

    Osaka, 5300025

  • Novo Nordisk Investigational Site

    Osaka-shi, Osaka, 545 8586

  • Novo Nordisk Investigational Site

    Shimotsuka-gun, 321 0293

  • Novo Nordisk Investigational Site

    Shimotsuke-shi, Tochigi, 329 0433

  • Novo Nordisk Investigational Site

    Shizuoka, 424 0853

  • Novo Nordisk Investigational Site

    Tagajō-shi, 985 0852

  • Novo Nordisk Investigational Site

    Yokohama, 235 0045

Other trials in Japan

About this study

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

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.

Being tested
biphasic insulin aspart 30, metformin, glimepiride, insulin glargine
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • biphasic insulin aspart 30Drug

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

  • metforminDrug

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

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

  • glimepirideDrug

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

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

  • insulin glargineDrug

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

Study groups in NCT01123980
Study groupRoleWhat they receive
BIAsp 30Experimental0.1-0.2 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
Receives: Drug: biphasic insulin aspart 30; Drug: metformin; Drug: glimepiride
Insulin glargineActive comparator0.1-0.2U/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
Receives: Drug: metformin; Drug: glimepiride; Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Measured: Week 0, week 24

Secondary outcomes (6)

  1. 9-point Plasma Glucose Profiles

    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.

    Measured: Week 24

  2. Percentage of Subjects Achieving HbA1c Below 7.0%

    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment

    Measured: Week 24

  3. Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment

    Measured: Week 24

  4. Number of Hypoglycaemic Episodes - All

    Measured: Weeks 0-24

  5. Number of Hypoglycaemic Episodes - Severe and Minor

    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.

    Measured: Weeks 0-24

  6. Number of Hypoglycaemic Episodes

    All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).

    Measured: Weeks 0-24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123980
Sponsor's protocol ID
BIASP-3756
Other IDs
U1111-1114-4112, JapicCTI-101139
Acronym
EasyMix
Status last verified
Jan 2017
First submitted
13 May 2010
Last updated
24 Feb 2017
Data monitoring committee
No

Publications

  • Yang W, Xu X, Liu X, Yang G, Seino Y, Andersen H, Jinnouchi H. Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naive subjects with type 2 diabetes. Curr Med Res Opin. 2013 Dec;29(12):1599-608. doi: 10.1185/03007995.2013.838155. Epub 2013 Sep 23.

    PubMed 23998560

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing biphasic insulin aspart 30, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01123980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.

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