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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dexa Medica Group

Criteria

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