PrediabeticPhase 3DIPPER-DMNCT01531933
Efficacy and Safety of DLBS3233 in Prediabetic Patients
A Phase 3 study testing DLBS3233 in people with Prediabetic, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233. It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prediabetic
- What is being tested?
- DLBS3233
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2011to Jul 2012
- 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
- Prediabetic patients (2h-PPPG level of 140-199 mg/dL)
- Serum ALT ≤ 2.5 times upper limit of normal
- Serum creatinine < 1.5 times upper limit of normal
- Able to take oral medication
Who cannot join
- Female of childbearing potential
- History of diabetes mellitus
- History of symptomatic coronary arterial disease, stroke, and cardiovascular events
- 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
1 site in 1 country.
Indonesia1 site
Department of Internal Medicine, dr. M. Djamil Padang Hospital
Padang, West Sumatera
About this study
Official title: Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.
It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.
Read the detailed description
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.
Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.
All subjects will be under direct supervision of a medical doctor during the study period.
All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
- Conditions
- Prediabetic
- Being tested
- DLBS3233, Placebo of DLBS3233
- Keywords
- Prediabetic, Primary prevention, Type 2 diabetes mellitus
- 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.
DLBS3233Drug
Also called Inlacin
For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
Placebo of DLBS3233Drug
For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
| Study group | Role | What they receive |
|---|---|---|
| DLBS3233 | Experimental | Not described Receives: Drug: DLBS3233 |
| Placebo of DLBS3233 | Placebo comparator | Not described Receives: Drug: Placebo of DLBS3233 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 15-minute post prandial insulin level
Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment
Measured: 12 weeks of treatment
Secondary outcomes (15)
Change in 15-minute post prandial insulin level
Change in 15-minute post prandial insulin level from baseline to 8 weeks of treatment
Measured: 8 weeks of treatment
Change in 2-hour post prandial insulin level
Change in 2-hour post prandial insulin level from baseline to 8 weeks and to 12 weeks of treatment
Measured: 8 weeks and 12 weeks of treatment
Change in 15-minute post prandial plasma glucose
Change in 15-minute post prandial plasma glucose from baseline to 8 weeks and to 12 weeks of treatment
Measured: 8 weeks and 12 weeks of treatment
Change in 2-hour post prandial plasma glucose
Change in 2-hour post prandial plasma glucose from baseline to each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)
Measured: 4 weeks, 8 weeks, and 12 weeks of treatment
Change in HOMA-IR
Change in HOMA-IR from baseline to 8 weeks and to 12 weeks of treatment
Measured: 8 weeks and 12 weeks of treatment
Change in hs-CRP
Change in hs-CRP from baseline to 8 weeks and to 12 weeks of treatment
Measured: 8 weeks and 12 weeks of treatment
Improvement in lipid profile
Improvement in lipid profile from baseline to 8 weeks and to 12 weeks of treatment, including: fasting plasma HDL-cholesterol, fasting plasma triglyceride, 15-minute post prandial plasma triglyceride, and 2-hour post prandial plasma triglyceride
Measured: 8 weeks and 12 weeks of treatment
Change in adiponectin
Change in adiponectin from baseline to 8 weeks and to 12 weeks of treatment
Measured: 8 weeks and 12 weeks of treatment
Change in waist-to-hip ratio
Change in waist-to-hip ratio from baseline to each of study visit (4 weeks, 8 weeks, and 12 weeks of treatment)
Measured: 4 weeks, 8 weeks, and 12 weeks of treatment
ECG
ECG will be evaluated at baseline and at end of study (12 weeks of treatment)
Measured: 12 weeks of treatment
Vital signs
Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate) will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)
Measured: 4 weeks, 8 weeks, and 12 weeks of treatment
Body weight
Body weight will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)
Measured: 4 weeks, 8 weeks, and 12 weeks of treatment
Liver function
Liver function (levels of serum ALT, γ-GT, alkaline phosphatase) will be evaluated at baseline and at end of study (12 weeks of treatment)
Measured: 12 weeks of treatment
Renal function
Renal function (serum creatinine level) will be evaluated at baseline and at end of study (12 weeks of treatment)
Measured: 12 weeks of treatment
Adverse events
Adverse events as well as number of subjects experienced the events will be observed and evaluated during study period (12 weeks) and until all adverse events have been recovered or stabilized
Measured: 1-12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asman Manaf, Prof., Dr., dr., SpPD-KEMD, Principal investigator, Department of Internal Medicine, dr. M. Djamil Padang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531933
- Sponsor's protocol ID
- DLBS3233-0711
- Acronym
- DIPPER-DM
- Status last verified
- Aug 2012
- First submitted
- 9 Feb 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]
- ClinicalTrials.gov ID
- NCT01531933
- Acronym / sponsor ID
- DIPPER-DM / DLBS3233-0711
- Conditions
- Prediabetic
- Keywords
- Prediabetic, Primary prevention, Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.
It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.
Detailed description
There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.
Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.
All subjects will be under direct supervision of a medical doctor during the study period.
All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLBS3233 | Experimental | Drug: DLBS3233 |
| Placebo of DLBS3233 | Placebo comparator | Drug: Placebo of DLBS3233 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects with age of 18-60 years
- Prediabetic patients (2h-PPPG level of 140-199 mg/dL)
- Serum ALT ≤ 2.5 times upper limit of normal
- Serum creatinine < 1.5 times upper limit of normal
- Able to take oral medication
Key exclusion criteria (6 listed)
- Female of childbearing potential
- History of diabetes mellitus
- History of symptomatic coronary arterial disease, stroke, and cardiovascular events
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DLBS3233Also: InlacinFor the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. | Drug | DLBS3233 |
| Placebo of DLBS3233For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. | Drug | Placebo of DLBS3233 |
Primary outcome
Change in 15-minute post prandial insulin level
Time frame: 12 weeks of treatment
Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment
15 secondary outcomes
Change in 15-minute post prandial insulin level
Time frame: 8 weeks of treatment
Change in 2-hour post prandial insulin level
Time frame: 8 weeks and 12 weeks of treatment
Change in 15-minute post prandial plasma glucose
Time frame: 8 weeks and 12 weeks of treatment
Change in 2-hour post prandial plasma glucose
Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment
Change in HOMA-IR
Time frame: 8 weeks and 12 weeks of treatment
Change in hs-CRP
Time frame: 8 weeks and 12 weeks of treatment
Improvement in lipid profile
Time frame: 8 weeks and 12 weeks of treatment
Change in adiponectin
Time frame: 8 weeks and 12 weeks of treatment
Change in waist-to-hip ratio
Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment
ECG
Time frame: 12 weeks of treatment
Vital signs
Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment
Body weight
Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment
Liver function
Time frame: 12 weeks of treatment
Renal function
Time frame: 12 weeks of treatment
Adverse events
Time frame: 1-12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asman Manaf, Prof., Dr., dr., SpPD-KEMD principal investigator
Department of Internal Medicine, dr. M. Djamil Padang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DLBS3233 in people with Prediabetic, 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 5 inclusion and 6 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 7 Aug 2012. 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?
Change in 15-minute post prandial insulin level (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2012.