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CompletedNCT01005069Updated Sep 28, 2010

Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

A Phase 2 interventional study of DLBS-32 and DLBS-32 in Diabetes Mellitus, Type 2, sponsored by Dexa Medica Group. Completed at 2 sites in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-09-28.

Sponsored by Dexa Medica Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • diabetes mellitus
  • DLBS-32
  • fasting plasma glucose
  • insulin resistance
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Dexa Medica Group is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Treatment I

    Drug: DLBS-32

  • Experimental
    Treatment II

    Drug: DLBS-32

  • Experimental
    Treatment III

    Drug: DLBS-32

  • Experimental
    Treatment IV

    Drug: DLBS-32

  • Placebo comparator
    Placebo

    Drug: Placebo capsule

Interventions

  • DrugDLBS-32

    DLBS-32 50 mg once daily and lifestyle modification

  • DrugDLBS-32

    DLBS-32 100 mg once daily and lifestyle modification

  • DrugDLBS-32

    DLBS-32 200 mg once daily and lifestyle modification

  • DrugDLBS-32

    DLBS-32 300 mg once daily and lifestyle modification

  • DrugPlacebo capsule

    Placebo capsules once daily and lifestyle modification

06

What researchers measure

Primary outcomes

  1. Reduction of venous Fasting Plasma Glucose from baseline

    Time frame: every 2-week interval over 6 weeks of treatment

Secondary outcomes

  1. Reduction of 2h-post-prandial plasma glucose from baseline

    Time frame: six weeks

  2. Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline

    Time frame: six weeks

  3. Change of high sensitivity C-reactive protein (hs-CRP) from baseline

    Time frame: six weeks

  4. Liver Function, Renal Function, Adverse events

    Time frame: six weeks

  5. Change in HbA1c from baseline

    Time frame: six weeks

  6. Change in lipid profile from baseline

    Time frame: six weeks

07

Study locations

2 sites
  • Sanglah Hospital Denpasar
    Denpasar, Bali, Indonesia
  • RSUD Tarakan
    Jakarta Pusat, DKI Jakarta, Indonesia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01005069
Lead sponsor
Dexa Medica Group
First posted
Oct 30, 2009
Start date
Oct 2009
Primary completion
Jul 2010
Completion
Aug 2010
Last update
Sep 28, 2010

Study contacts

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
View the source record on ClinicalTrials.gov ↗

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