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

October 28, 2009
September 26, 2010
October 2009
July 2010   (final data collection date for primary outcome measure)
Reduction of venous Fasting Plasma Glucose from baseline [ Time Frame: every 2-week interval over 6 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01005069 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01005069
DLBS-32-0309
Not Provided
Not Provided
Dexa Medica Group
Not Provided
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
Dexa Medica Group
September 2010

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