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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

DLBS-32

Placebo capsule

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sanglah Hospital Denpasar
RSUD Tarakan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment I

Treatment II

Treatment III

Treatment IV

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reduction of venous Fasting Plasma Glucose from baseline

Secondary Outcome Measures

Reduction of 2h-post-prandial plasma glucose from baseline

Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline

Change of high sensitivity C-reactive protein (hs-CRP) from baseline

Liver Function, Renal Function, Adverse events

Change in HbA1c from baseline

Change in lipid profile from baseline

Full Information

NCT ID

NCT01005069

First Posted

October 28, 2009

Last Updated

September 26, 2010

Sponsor

Dexa Medica Group

1. Study Identification

Unique Protocol Identification Number

NCT01005069

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dexa Medica Group

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, DLBS-32, fasting plasma glucose, insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment I

Arm Type

Experimental

Arm Title

Treatment II

Arm Type

Experimental

Arm Title

Treatment III

Arm Type

Experimental

Arm Title

Treatment IV

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

DLBS-32

Intervention Description

DLBS-32 50 mg once daily and lifestyle modification

Intervention Type

Drug

Intervention Name(s)

DLBS-32

Intervention Description

DLBS-32 100 mg once daily and lifestyle modification

Intervention Type

Drug

Intervention Name(s)

DLBS-32

Intervention Description

DLBS-32 200 mg once daily and lifestyle modification

Intervention Type

Drug

Intervention Name(s)

DLBS-32

Intervention Description

DLBS-32 300 mg once daily and lifestyle modification

Intervention Type

Drug

Intervention Name(s)

Placebo capsule

Intervention Description

Placebo capsules once daily and lifestyle modification

Primary Outcome Measure Information:

Title

Reduction of venous Fasting Plasma Glucose from baseline

Time Frame

every 2-week interval over 6 weeks of treatment

Secondary Outcome Measure Information:

Title

Reduction of 2h-post-prandial plasma glucose from baseline

Time Frame

six weeks

Title

Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline

Time Frame

six weeks

Title

Change of high sensitivity C-reactive protein (hs-CRP) from baseline

Time Frame

six weeks

Title

Liver Function, Renal Function, Adverse events

Time Frame

six weeks

Title

Change in HbA1c from baseline

Time Frame

six weeks

Title

Change in lipid profile from baseline

Time Frame

six weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ketut Suastika, Prof. Dr.

Organizational Affiliation

Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nuniek E Nugrahini, Dr.

Organizational Affiliation

Department of internal medicine, RSUD Tarakan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanglah Hospital Denpasar

City

Denpasar

State/Province

Bali

Country

Indonesia

Facility Name

RSUD Tarakan

City

Jakarta Pusat

State/Province

DKI Jakarta

Country

Indonesia

12. IPD Sharing Statement

Learn more about this trial

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

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