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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005069

Enrollment

Registered

2009-10-30

Start date

2009-10-31

Completion date

2010-08-31

Last updated

2010-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance

Brief 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.

Interventions

DRUGDLBS-32

DLBS-32 50 mg once daily and lifestyle modification

DRUGPlacebo capsule

Placebo capsules once daily and lifestyle modification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
Reduction of venous Fasting Plasma Glucose from baseline	every 2-week interval over 6 weeks of treatment

Secondary

Measure	Time frame
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline	six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline	six weeks
Reduction of 2h-post-prandial plasma glucose from baseline	six weeks
Change in HbA1c from baseline	six weeks
Change in lipid profile from baseline	six weeks
Liver Function, Renal Function, Adverse events	six weeks

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026