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

NCT ID: NCT01005069

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment I

Group Type EXPERIMENTAL

DLBS-32

Intervention Type DRUG

DLBS-32 50 mg once daily and lifestyle modification

Treatment II

Group Type EXPERIMENTAL

DLBS-32

Intervention Type DRUG

DLBS-32 100 mg once daily and lifestyle modification

Treatment III

Group Type EXPERIMENTAL

DLBS-32

Intervention Type DRUG

DLBS-32 200 mg once daily and lifestyle modification

Treatment IV

Group Type EXPERIMENTAL

DLBS-32

Intervention Type DRUG

DLBS-32 300 mg once daily and lifestyle modification

Placebo

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DRUG

Placebo capsules once daily and lifestyle modification

Interventions

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DLBS-32

DLBS-32 50 mg once daily and lifestyle modification

Intervention Type DRUG

DLBS-32

DLBS-32 100 mg once daily and lifestyle modification

Intervention Type DRUG

DLBS-32

DLBS-32 200 mg once daily and lifestyle modification

Intervention Type DRUG

DLBS-32

DLBS-32 300 mg once daily and lifestyle modification

Intervention Type DRUG

Placebo capsule

Placebo capsules once daily and lifestyle modification

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dexa Medica Group

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ketut Suastika, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital

Nuniek E Nugrahini, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of internal medicine, RSUD Tarakan

Locations

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Sanglah Hospital Denpasar

Denpasar, Bali, Indonesia

Site Status

RSUD Tarakan

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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DLBS-32-0309

Identifier Type: -

Identifier Source: org_study_id