Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

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

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-09-30

Brief Summary

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This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

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Detailed Description

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There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Conditions

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Type-2-diabetes Mellitus New Onset

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 (control)

Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification

Group Type PLACEBO_COMPARATOR

Placebo of DLBS3233

Intervention Type DRUG

Placebo of DLBS3233 once daily for 12 weeks

Lifestyle modification

Intervention Type OTHER

Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Treatment II

100 mg DLBS3233 once daily for 12 weeks + lifestyle modification

Group Type EXPERIMENTAL

DLBS3233

Intervention Type DRUG

100 mg DLBS3233 once daily for 12 weeks

Lifestyle modification

Intervention Type OTHER

Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Interventions

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Placebo of DLBS3233

Placebo of DLBS3233 once daily for 12 weeks

Intervention Type DRUG

DLBS3233

100 mg DLBS3233 once daily for 12 weeks

Intervention Type DRUG

Lifestyle modification

Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.

Intervention Type OTHER

Other Intervention Names

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Placebo of Inlacin Inlacin

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects with age of 18-60 years
* BMI ≥ 18.5 kg/m2
* Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
* FPG ≤ 183 mg/dL
* Hemoglobin level of ≥ 10.0 g/dL
* Serum ALT ≤ 2.5 times upper limit of normal
* Serum creatinine \< 1.5 times upper limit of normal

Exclusion Criteria

* Female of childbearing potential
* Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
* Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg)
* History of renal and/or liver disease
* History of or the presence of any clinical evidence of malignancies
* Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Participation in any other intervention trial within 30 days prior to Screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No