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Type-2-diabetes MellitusPhase 3NCT01645332

Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

A Phase 3 study testing DLBS3233 and Lifestyle modification in people with Type-2-diabetes Mellitus and New Onset, run by Dexa Medica Group at 1 site 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 a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type-2-diabetes Mellitus, New Onset
What is being tested?
DLBS3233 and Lifestyle modification
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteIndonesia
Study dates
Jul 2012to Sep 2014
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female subjects with age of 18-60 years
  • BMI ≥ 18.5 kg/m2
  • Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
  • FPG ≤ 183 mg/dL
  • Hemoglobin level of ≥ 10.0 g/dL
  • Serum ALT ≤ 2.5 times upper limit of normal
  • Serum creatinine < 1.5 times upper limit of normal

Who cannot join

  • Female of childbearing potential
  • Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
  • Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg)
  • History of renal and/or liver disease
  • History of or the presence of any clinical evidence of malignancies
  • Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
  • Current treatment with systemic corticosteroids or herbal (alternative) medicines
  • Participation in any other intervention trial within 30 days prior to Screening

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital

    Semarang, Central Java, 50231

Other trials in Indonesia

About this study

Official title: Role of DLBS3233 in the Treatment of Subjects With New Onset of Type 2 Diabetes Mellitus

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

Read the detailed description

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Being tested
Placebo of DLBS3233, DLBS3233, Lifestyle modification
Keywords
DLBS3233, new onset, type-2-diabetes mellitus, oral anti-hyperglycemic agent

What participants receive

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

  • Placebo of DLBS3233Drug

    Also called Placebo of Inlacin

    Placebo of DLBS3233 once daily for 12 weeks

  • DLBS3233Drug

    Also called Inlacin

    100 mg DLBS3233 once daily for 12 weeks

  • Lifestyle modificationOther

    Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Study groups in NCT01645332
Study groupRoleWhat they receive
Treatment I (control)Placebo comparatorPlacebo of DLBS3233 once daily for 12 weeks + lifestyle modification
Receives: Drug: Placebo of DLBS3233; Other: Lifestyle modification
Treatment IIExperimental100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
Receives: Drug: DLBS3233; Other: Lifestyle modification

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 to Week 12 of treatment

    Measured: 12 weeks

Secondary outcomes (14)

  1. Reduction of venous FPG

    Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment

    Measured: 6 weeks and 12 weeks

  2. Reduction of venous 2h-PG

    Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment

    Measured: 6 weeks and 12 weeks

  3. Response rate

    Percentage of subjects with FPG < 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment

    Measured: 12 weeks

  4. Change in fasting insulin level

    Change in fasting insulin level from baseline to Week 12 of treatment

    Measured: 12 weeks

  5. Change in HOMA-IR

    Change in HOMA-IR from baseline to Week 12 of treatment

    Measured: 12 weeks

  6. Change in HOMA-B

    Change in HOMA-B from baseline to Week 12 of treatment

    Measured: 12 weeks

  7. Change in adiponectin level

    Change in adiponectin level from baseline to Week 12 of treatment

    Measured: 12 weeks

  8. Change in lipid profile

    Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment

    Measured: 12 weeks

  9. Change in body weight

    Change in body weight from baseline to Week 6 and Week 12 of treatment

    Measured: 6 weeks and 12 weeks

  10. Vital signs

    Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12

    Measured: 6 weeks and 12 weeks

  11. Liver function

    Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12

    Measured: 12 weeks

  12. Renal function

    Renal function (serum creatinine level) will be evaluated at baseline and Week 12

    Measured: 12 weeks

  13. Electrocardiography (ECG)

    ECG will be evaluated at baseline and Week 12

    Measured: 12 weeks

  14. Adverse events

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

    Measured: 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 posted20 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionAug 2014
  4. Study completionSep 2014

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01645332
Sponsor's protocol ID
DLBS3233-0912
Status last verified
Oct 2014
First submitted
18 Jul 2012
Last updated
8 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DLBS3233 and Lifestyle modification in people with Type-2-diabetes Mellitus and New Onset, run by Dexa Medica Group at 1 site 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 7 inclusion and 8 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 8 Oct 2014. 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 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. Some participants in this study may receive a placebo. 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 NCT01645332.

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 8 Oct 2014.

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