Diabetes Mellitus, Type 2Phase 2NCT01005069
Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
A Phase 2 study testing DLBS-32 in people with Diabetes Mellitus, Type 2, run by Dexa Medica Group at 2 sites in Indonesia.
Trial summary
The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- DLBS-32
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesIndonesia
- Study dates
- Oct 2009to Aug 2010
- Phase
- Phase 2
- 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
- Fasting capillary blood glucose of 127-249 mg/dL at screening
- BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female)
- Normal liver function
- Normal renal function
- OHA-naive type-II-diabetic patients
Who cannot join
- Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Uncontrolled hypertension
- History of or current treatment with insulin
- Current treatment with systemic corticosteroids or herbal (alternative) medicines
- History of renal and/or liver disease
- Pregnant or breast feeding females
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Sanglah Hospital Denpasar
Denpasar, Bali
RSUD Tarakan
Jakarta Pusat, DKI Jakarta
About this study
Official title: Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- DLBS-32, Placebo capsule
- Keywords
- diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLBS-32Drug
DLBS-32 50 mg once daily and lifestyle modification
DLBS-32Drug
DLBS-32 100 mg once daily and lifestyle modification
DLBS-32Drug
DLBS-32 200 mg once daily and lifestyle modification
DLBS-32Drug
DLBS-32 300 mg once daily and lifestyle modification
Placebo capsuleDrug
Placebo capsules once daily and lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| Treatment I | Experimental | Not described Receives: Drug: DLBS-32 |
| Treatment II | Experimental | Not described Receives: Drug: DLBS-32 |
| Treatment III | Experimental | Not described Receives: Drug: DLBS-32 |
| Treatment IV | Experimental | Not described Receives: Drug: DLBS-32 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of venous Fasting Plasma Glucose from baseline
Measured: every 2-week interval over 6 weeks of treatment
Secondary outcomes (6)
Reduction of 2h-post-prandial plasma glucose from baseline
Measured: six weeks
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline
Measured: six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline
Measured: six weeks
Liver Function, Renal Function, Adverse events
Measured: six weeks
Change in HbA1c from baseline
Measured: six weeks
Change in lipid profile from baseline
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ketut Suastika, Prof. Dr., Principal investigator, Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar HospitalNuniek E Nugrahini, Dr., Principal investigator, Department of internal medicine, RSUD Tarakan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005069
- Sponsor's protocol ID
- DLBS-32-0309
- Status last verified
- Sep 2010
- First submitted
- 28 Oct 2009
- Last updated
- 28 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01005069
- Acronym / sponsor ID
- DLBS-32-0309
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Oct 2009 (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.
The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment I | Experimental | Drug: DLBS-32 |
| Treatment II | Experimental | Drug: DLBS-32 |
| Treatment III | Experimental | Drug: DLBS-32 |
| Treatment IV | Experimental | Drug: DLBS-32 |
| Placebo | Placebo comparator | Drug: Placebo capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fasting capillary blood glucose of 127-249 mg/dL at screening
- BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female)
- Normal liver function
- Normal renal function
- OHA-naive type-II-diabetic patients
Key exclusion criteria (6 listed)
- Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Uncontrolled hypertension
- History of or current treatment with insulin
- Current treatment with systemic corticosteroids or herbal (alternative) medicines
- History of renal and/or liver disease
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 |
|---|---|---|
| DLBS-32DLBS-32 50 mg once daily and lifestyle modification | Drug | Treatment I |
| DLBS-32DLBS-32 100 mg once daily and lifestyle modification | Drug | Treatment II |
| DLBS-32DLBS-32 200 mg once daily and lifestyle modification | Drug | Treatment III |
| DLBS-32DLBS-32 300 mg once daily and lifestyle modification | Drug | Treatment IV |
| Placebo capsulePlacebo capsules once daily and lifestyle modification | Drug | Placebo |
Primary outcome
Reduction of venous Fasting Plasma Glucose from baseline
Time frame: every 2-week interval over 6 weeks of treatment
6 secondary outcomes
Reduction of 2h-post-prandial plasma glucose from baseline
Time frame: six weeks
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline
Time frame: six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline
Time frame: six weeks
Liver Function, Renal Function, Adverse events
Time frame: six weeks
Change in HbA1c from baseline
Time frame: six weeks
Change in lipid profile from baseline
Time frame: six weeks
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 28 Sep 2010.
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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.
Ketut Suastika, Prof. Dr. principal investigator
Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital
Nuniek E Nugrahini, Dr. principal investigator
Department of internal medicine, RSUD Tarakan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DLBS-32 in people with Diabetes Mellitus, Type 2, 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 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 28 Sep 2010. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 venous Fasting Plasma Glucose from baseline (time frame: every 2-week interval over 6 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 28 Sep 2010.