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Type 2 Diabetes MellitusPhase 4OPENINGNCT01338376

Organization Program of DiabEtes INsulIN ManaGement

A Phase 4 study testing Structured Education, Conventional Diabetes Education and Scilin®M30 in people with Type 2 Diabetes Mellitus, run by Chinese Diabetes Society at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Structured Education, Conventional Diabetes Education and Scilin®M30
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteChina
Study dates
Mar 2011to May 2012
Phase
Phase 4
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written Informed Consent obtained before any trial-related activities Type 2 DM subjects;
  • Age > 18 years old,male or female;
  • Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c>7.5%;
  • Cooperative with structured management;

Who cannot join

  • Subjects with type 1 diabetes;
  • Gestational diabetes mellitus and other specific types DM;
  • Those who are unwilling to sign in ICF;
  • Subjects with repeated hypoglycemia;
  • Subjects with BMI>30kg/m2;
  • Impaired liver function,defined as alanine aminotransferase (ALAT)>= 2.5 or alkaline phosphatase (ALP)>= 2 times upper referenced limit times upper normal limit;
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  • Females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice);
  • Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation;
  • Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation;
  • Malignant neoplastic diseases (except carcinoma in situ);
  • Current addiction to alcohol or other addictive substances;

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Peking University First Hospital, 3A grade, +86 10 83572211, dyyy@bddyyy.com.cn

    Recruiting

Other trials in China

About this study

Official title: Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study

Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.

Read the detailed description

This is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with Type 2 DM will be enrolled and be randomized into Structured Education Group and Conventional Education Group in 1:1 ratio. Subjects in both of the groups will be treated with Scilin®M30 twice daily (30 minutes before breakfast and dinner). All the previous oral antidiabetic drugs (OAD(s)) will be discontinued except metformin and alpha-Glucosidase Inhibitors. The physician will determine the starting dose (0.3 IU/kg～0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks.

Being tested
Structured Education, Conventional Diabetes Education, Scilin®M30
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Structured EducationBehavioural

    All of the educators who are responsible for the intensive group will be trained with the standard contents before the study kick-off.

    • Educator Activities: insulin injection, SMBG instruction, self-learned manuals, periodic assessment for subjects, subject counseling, self-care education (healthy eating, exercise, weight control), prevention and treatment of hypoglycemia complication education ,newsletter delivered by SMS
    • Physician Activity: frequent insulin titration

  • Conventional Diabetes EducationBehavioural

    The activities of the educators who are responsible for conventional group are identical with their routine clinical practice.

    • Educator Activities: insulin injection, SMBG instruction, healthy eating , prevention and treatment of hypoglycemia
    • Physician Activity: less frequent insulin titration

  • Scilin®M30Drug

    Subjects will be treated with Scilin®M30 twice daily

Study groups in NCT01338376
Study groupRoleWhat they receive
Structured Education GroupExperimentalSubjects received structured diabetes education
Receives: Behavioral: Structured Education; Drug: Scilin®M30
Conventional Care Group:Active comparatorSubjects received conventional diabetes education
Receives: Behavioral: Conventional Diabetes Education; Drug: Scilin®M30

What is being measured

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

  1. HbA1c

    Investigate glycemic control as measured by HbA1c change

    Measured: Screen,16weeks

Secondary outcomes (8)

  1. Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)

    Measured: Screen,16weeks

  2. Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)

    Measured: Screen,16weeks

  3. The satisfaction degree of structured management

    Measured: Screen,2weeks,4weeks,8weeks,12weeks,16weeks

  4. total daily insulin dose

    Measured: 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks

  5. 7-points of glucose

    glucose before breakfast;glucose two hours after breakfast;glucose before lunch;glucose two hours after lunch;glucose before dinner;glucose two hours after dinner;glucose before sleep

    Measured: Screen,16weeks

  6. body weight

    Measured: baseline,2weeks,4weeks,8weeks,12weeks,16weeks

  7. Medication compliance

    Measured: Screen,16weeks

  8. The incidence of Hypoglycemia

    Measured: 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks

Timeline

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

  1. First posted19 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionMar 2012 (estimated)
  4. Study completionMay 2012 (estimated)

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
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338376
Sponsor's protocol ID
Scilin20110124
Acronym
OPENING
Status last verified
Apr 2011
First submitted
15 Apr 2011
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Guo XH, Ji LN, Lu JM, Liu J, Lou QQ, Liu J, Shen L, Zhang MX, Lv XF, Gu MJ. Efficacy of structured education in patients with type 2 diabetes mellitus receiving insulin treatment. J Diabetes. 2014 Jul;6(4):290-7. doi: 10.1111/1753-0407.12100. Epub 2013 Nov 26.

    PubMed 24279284

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Structured Education, Conventional Diabetes Education and Scilin®M30 in people with Type 2 Diabetes Mellitus, run by Chinese Diabetes Society at 1 site in China.

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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Screen,16weeks). 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 NCT01338376, 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 12 Oct 2011.

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