Trial | NCT01645332  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dlbs3233 ...

  • Study Participants

    104
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 Started
Jul 31
2012
Primary Completion
Aug 31
2014
Study Completion
Sep 30
2014
Last Update
Oct 08
2014
Estimate

Drug Placebo of DLBS3233

Placebo of DLBS3233 once daily for 12 weeks

  • Other names: Placebo of Inlacin

Drug DLBS3233

100 mg DLBS3233 once daily for 12 weeks

  • Other names: Inlacin

Other 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.

Treatment I (control) Placebo Comparator

Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification

Treatment II Experimental

100 mg DLBS3233 once daily for 12 weeks + lifestyle modification

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
No Results Posted