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

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.

Study Overview

• Status: Completed
• Conditions: Type-2-diabetes Mellitus; New Onset
• Intervention / Treatment: Drug: Placebo of DLBS3233; Other: Lifestyle modification; Drug: DLBS3233

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Tengah
    • Semarang, Jawa Tengah, Indonesia, 50231
      • Division of Endocrinology, Department of Internal Medicine, Dr. Kariadi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Treatment I (control); Placebo of DLBS3233 once daily for 12 weeks + lifestyle modification	Drug: Placebo of DLBS3233; Placebo of DLBS3233 once daily for 12 weeks; Other Names: Placebo of 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.
EXPERIMENTAL: Treatment II; 100 mg DLBS3233 once daily for 12 weeks + lifestyle modification	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.; Drug: DLBS3233; 100 mg DLBS3233 once daily for 12 weeks; Other Names: Inlacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of A1c level	Reduction of A1c level from baseline to Week 12 of treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of venous FPG	Reduction of venous FPG from baseline to Week 6 and Week 12 of treatment	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	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	12 weeks
Change in fasting insulin level	Change in fasting insulin level from baseline to Week 12 of treatment	12 weeks
Change in HOMA-IR	Change in HOMA-IR from baseline to Week 12 of treatment	12 weeks
Change in HOMA-B	Change in HOMA-B from baseline to Week 12 of treatment	12 weeks
Change in adiponectin level	Change in adiponectin level from baseline to Week 12 of treatment	12 weeks
Change in lipid profile	Change in lipid profile (LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglyceride levels) from baseline to Week 12 of treatment	12 weeks
Change in body weight	Change in body weight from baseline to Week 6 and Week 12 of treatment	6 weeks and 12 weeks
Vital signs	Vital signs (blood pressure, heart rate, respiratory rate) will be measured at baseline, Week 6, and Week 12	6 weeks and 12 weeks
Liver function	Liver function (serum ALT, serum AST, serum γ-glutamyl transferase levels) will be evaluated at baseline and Week 12	12 weeks
Renal function	Renal function (serum creatinine level) will be evaluated at baseline and Week 12	12 weeks
Electrocardiography (ECG)	ECG will be evaluated at baseline and Week 12	12 weeks
Adverse events	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	12 weeks

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Heri Nugroho, Dr,dr,SpPD,KEMD,FINASIM, Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University, Dr. Kariadi Hospital, Semarang, Indonesia

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (ESTIMATE): July 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2014
• Last Update Submitted That Met QC Criteria: October 7, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: new onset; DLBS3233; type-2-diabetes mellitus; oral anti-hyperglycemic agent
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DLBS3233-0912