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

This study has been completed.

Sponsor:

Information provided by:

Dexa Medica Group

ClinicalTrials.gov Identifier:

NCT01005069

First received: October 28, 2009

Last updated: September 26, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 28, 2009

Last Updated Date

September 26, 2010

Start Date ^ICMJE

October 2009

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of venous Fasting Plasma Glucose from baseline [ Time Frame: every 2-week interval over 6 weeks of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01005069 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction of 2h-post-prandial plasma glucose from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Change of high sensitivity C-reactive protein (hs-CRP) from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Liver Function, Renal Function, Adverse events [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
Change in HbA1c from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Change in lipid profile from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Reduction of 2h-post-prandial plasma glucose from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Change of high sensitivity C-reactive protein (hs-CRP) from baseline [ Time Frame: six weeks ] [ Designated as safety issue: No ]
Liver Function, Renal Function, Adverse events [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

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
Drug: Placebo capsule
Placebo capsules once daily and lifestyle modification

Study Arm (s)

Experimental: Treatment I
Intervention: Drug: DLBS-32
Experimental: Treatment II
Intervention: Drug: DLBS-32
Experimental: Treatment III
Intervention: Drug: DLBS-32
Experimental: Treatment IV
Intervention: Drug: DLBS-32
Placebo Comparator: Placebo
Intervention: Drug: Placebo capsule

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Indonesia

Administrative Information

NCT Number ^ICMJE

NCT01005069

Other Study ID Numbers ^ICMJE

DLBS-32-0309

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Dexa Medica Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Dexa Medica Group

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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