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Type-2 Diabetes MellitusPhase 3NCT01472614

Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

A Phase 3 study testing DLBS3233 in people with Type-2 Diabetes Mellitus, run by Dexa Medica Group at 2 sites in Indonesia.

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 is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Type-2 Diabetes Mellitus
What is being tested?
DLBS3233
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesIndonesia
Study dates
Sep 2011to Apr 2013
Phase
Phase 3
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening
  • Diagnosed with type-2 diabetes mellitus
  • Have been being treated with a combination of two OHA for at least 3 months prior to screening
  • A1c level of >= 7.0 %
  • Hemoglobin level of >= 10 g/dL
  • Body Mass Index (BMI) > 18.5 kg/m2
  • Refuse insulin therapy
  • Able to take oral medicine

Who cannot join

  • Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  • History of or current chronic treatment with insulin
  • History of renal and/or liver disease
  • Impaired liver function: serum ALT > 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test
  • Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
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  • Current treatment with systemic corticosteroids or herbal (alternative) medicines
  • Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation
  • Participation in any other clinical studies within 30 days prior to screening

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Private Clinic at Jl. Prof. Dr. Moestopo 164

    Surabaya, East Java

  • Surabaya Diabetes and Nutrition Centre, Dr. Soetomo Hospital

    Surabaya, East Java

Other trials in Indonesia

About this study

Official title: Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

Read the detailed description

There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Being tested
DLBS3233
Keywords
Type-2 diabetes mellitus, Add-on therapy

What participants receive

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

  • DLBS3233Drug

    Also called Inlacin

    Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Study groups in NCT01472614
Study groupRoleWhat they receive
DLBS3233ExperimentalNot described
Receives: Drug: DLBS3233

What is being measured

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

  1. Reduction of A1c level

    Reduction of A1c level from baseline after 12 weeks of treatment

    Measured: 12 weeks

Secondary outcomes (13)

  1. Reduction of venous A1c level

    Reduction of venous A1c level from baseline to 6 weeks of treatment

    Measured: 6 weeks

  2. Reduction of venous FPG

    Reduction of venous FPG from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  3. Reduction of venous 1h-PG

    Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  4. Change in fasting insulin level

    Change in fasting insulin level from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  5. Change in HOMA-R

    Change in HOMA-R from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  6. Change in HOMA-B

    Change in HOMA-B from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  7. Change in adiponectin level

    Change in adiponectin level from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  8. Change in lipid profile

    Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides

    Measured: 6 and 12 weeks

  9. Change in body weight

    Change in body weight from baseline to every evaluation-time point

    Measured: 6 and 12 weeks

  10. Hematology

    Hematology parameters (Hemoglobin level, Hematocrit, Red Blood Cell count, White Blood Cell count as well as its differentials, and platelet count) will be evaluated at baseline, at interval of 6 weeks, and at the end of study

    Measured: 6 and 12 weeks

  11. Liver function

    Liver function parameters (serum ALT, serum AST, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin levels) will be measured at baseline, at interval of 6 weeks, and at the end of study

    Measured: 6 and 12 weeks

  12. Renal function

    Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study

    Measured: 6 and 12 weeks

  13. Adverse events

    Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (12 weeks) and until all adverse events have been recovered or stabilized.

    Measured: 1-12 weeks

Timeline

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

  1. First posted16 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2013
  4. Study completionApr 2013

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472614
Sponsor's protocol ID
DLBS3233-0411
Status last verified
May 2013
First submitted
11 Nov 2011
Last updated
27 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DLBS3233 in people with Type-2 Diabetes Mellitus, run by Dexa Medica Group at 2 sites in Indonesia.

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 8 inclusion and 9 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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Reduction of A1c level (time frame: 12 weeks). 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 NCT01472614.

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 27 May 2013.

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