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

Dexa Medica Group104 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Type-2-diabetes Mellitus New Onset

Interventions

Placebo of DLBS3233DRUG

Placebo of DLBS3233 once daily for 12 weeks

DLBS3233DRUG

100 mg DLBS3233 once daily for 12 weeks

Lifestyle modificationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital

Semarang, Central Java, Indonesia

Outcomes

Primary Outcomes

Reduction of A1c level

Reduction of A1c level from baseline to Week 12 of treatment

Time frame: 12 weeks

Secondary Outcomes

Reduction of venous FPG

Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment

Time frame: 6 weeks and 12 weeks

Reduction of venous 2h-PG

Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment

Time frame: 6 weeks and 12 weeks

Response rate

Percentage of subjects with FPG \< 110 mg/dL and/or reduction of at least 10% in FPG level from baseline to Week 12 of treatment

Time frame: 12 weeks

Change in fasting insulin level

Change in fasting insulin level from baseline to Week 12 of treatment

Time frame: 12 weeks

Change in HOMA-IR

Change in HOMA-IR from baseline to Week 12 of treatment

Time frame: 12 weeks

Change in HOMA-B

Change in HOMA-B from baseline to Week 12 of treatment

Time frame: 12 weeks

Change in adiponectin level

Change in adiponectin level from baseline to Week 12 of treatment

Time frame: 12 weeks

Change in lipid profile

Data from ClinicalTrials.gov

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