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

Tracking Information
First Submitted Date ICMJE	October 28, 2009
First Posted Date ICMJE	October 30, 2009
Last Update Posted Date	September 28, 2010
Study Start Date ICMJE	October 2009
Actual Primary Completion Date	July 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 29, 2009)	Reduction of venous Fasting Plasma Glucose from baseline [ Time Frame: every 2-week interval over 6 weeks of treatment ]
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; (submitted: December 31, 2009)	Reduction of 2h-post-prandial plasma glucose from baseline [ Time Frame: six weeks ]; Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline [ Time Frame: six weeks ]; Change of high sensitivity C-reactive protein (hs-CRP) from baseline [ Time Frame: six weeks ]; Liver Function, Renal Function, Adverse events [ Time Frame: six weeks ]; Change in HbA1c from baseline [ Time Frame: six weeks ]; Change in lipid profile from baseline [ Time Frame: six weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: October 29, 2009)	Reduction of 2h-post-prandial plasma glucose from baseline [ Time Frame: six weeks ]; Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline [ Time Frame: six weeks ]; Change of high sensitivity C-reactive protein (hs-CRP) from baseline [ Time Frame: six weeks ]; Liver Function, Renal Function, Adverse events [ Time Frame: six weeks ]
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; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, 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 Arms	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
Actual Enrollment ICMJE; (submitted: September 26, 2010)	72
Original Estimated Enrollment ICMJE; (submitted: October 29, 2009)	100
Actual Study Completion Date	August 2010
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Indonesia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01005069
Other Study ID Numbers ICMJE	DLBS-32-0309
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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