Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: DLBS-32; Drug: DLBS-32; Drug: DLBS-32; Drug: DLBS-32; Drug: Placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia
      • Sanglah Hospital Denpasar
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia
      • RSUD Tarakan

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:

• Fasting capillary blood glucose of 127-249 mg/dL at screening
• BMI >= 18.5 kg/m^2 or waist circumference of >= 90 cm (male) or >= 80 cm (female)
• Normal liver function
• Normal renal function
• OHA-naive type-II-diabetic patients

Exclusion Criteria:

• Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Uncontrolled hypertension
• History of or current treatment with insulin
• Current treatment with systemic corticosteroids or herbal (alternative) medicines
• History of renal and/or liver disease
• Pregnant or breast feeding females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo capsule; Placebo capsules once daily and lifestyle modification
Experimental: Treatment I	Drug: DLBS-32; DLBS-32 50 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 100 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 200 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 300 mg once daily and lifestyle modification
Experimental: Treatment II	Drug: DLBS-32; DLBS-32 50 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 100 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 200 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 300 mg once daily and lifestyle modification
Experimental: Treatment III	Drug: DLBS-32; DLBS-32 50 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 100 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 200 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 300 mg once daily and lifestyle modification
Experimental: Treatment IV	Drug: DLBS-32; DLBS-32 50 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 100 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 200 mg once daily and lifestyle modification; Drug: DLBS-32; DLBS-32 300 mg once daily and lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of venous Fasting Plasma Glucose from baseline	every 2-week interval over 6 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction of 2h-post-prandial plasma glucose from baseline	six weeks
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline	six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline	six weeks
Liver Function, Renal Function, Adverse events	six weeks
Change in HbA1c from baseline	six weeks
Change in lipid profile from baseline	six weeks

Collaborators and Investigators

• Sponsor: Dexa Medica Group
• Investigators: Principal Investigator: Ketut Suastika, Prof. Dr., Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital; Principal Investigator: Nuniek E Nugrahini, Dr., Department of internal medicine, RSUD Tarakan

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): September 28, 2010
• Last Update Submitted That Met QC Criteria: September 26, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: insulin resistance; diabetes mellitus; fasting plasma glucose; DLBS-32
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DLBS-32-0309