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

Dexa Medica

Status and phase: Completed; Phase 3

Conditions: Type-2-diabetes Mellitus; New Onset

Treatments: Drug: DLBS3233; Other: Lifestyle modification; Drug: Placebo of DLBS3233

Study type: Interventional

Funder types: Industry

Identifiers

NCT01645332

DLBS3233-0912

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Treatment I (control)

Placebo Comparator group

Description:

Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification

Treatment:

Other: Lifestyle modification

Drug: Placebo of DLBS3233

Treatment II

Experimental group

Description:

100 mg DLBS3233 once daily for 12 weeks + lifestyle modification

Treatment:

Other: Lifestyle modification

Drug: DLBS3233