Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
- Conditions
- New OnsetType-2-diabetes Mellitus
- Interventions
- Registration Number
- NCT01645332
- Lead Sponsor
- Dexa Medica Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment I (control) Placebo of DLBS3233 Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification Treatment I (control) Lifestyle modification Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification Treatment II Lifestyle modification 100 mg DLBS3233 once daily for 12 weeks + lifestyle modification Treatment II DLBS3233 100 mg DLBS3233 once daily for 12 weeks + lifestyle modification
- Primary Outcome Measures
Name Time Method Reduction of A1c level 12 weeks Reduction of A1c level from baseline to Week 12 of treatment
- Secondary Outcome Measures
Name Time Method Change in HOMA-B 12 weeks Change in HOMA-B from baseline to Week 12 of treatment
Reduction of venous FPG 6 weeks and 12 weeks Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment
Response rate 12 weeks 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
Change in fasting insulin level 12 weeks Change in fasting insulin level from baseline to Week 12 of treatment
Liver function 12 weeks Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12
Change in adiponectin level 12 weeks Change in adiponectin level from baseline to Week 12 of treatment
Change in lipid profile 12 weeks Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment
Vital signs 6 weeks and 12 weeks Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12
Renal function 12 weeks Renal function (serum creatinine level) will be evaluated at baseline and Week 12
Adverse events 12 weeks Adverse events as well as number of subjects experienced the events will be observed and evaluated throughout study period (12 weeks) and until all adverse events have been recovered or stabilized
Reduction of venous 2h-PG 6 weeks and 12 weeks Reduction of venous 2h-PG from baseline to Week 6 and Week 12 of treatment
Change in HOMA-IR 12 weeks Change in HOMA-IR from baseline to Week 12 of treatment
Change in body weight 6 weeks and 12 weeks Change in body weight from baseline to Week 6 and Week 12 of treatment
Electrocardiography (ECG) 12 weeks ECG will be evaluated at baseline and Week 12
Trial Locations
- Locations (1)
Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital
🇮🇩Semarang, Jawa Tengah, Indonesia