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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: DLBS-32
Drug: Placebo capsule
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment I Drug: DLBS-32
DLBS-32 50 mg once daily and lifestyle modification
Experimental: Treatment II Drug: DLBS-32
DLBS-32 100 mg once daily and lifestyle modification
Experimental: Treatment III Drug: DLBS-32
DLBS-32 200 mg once daily and lifestyle modification
Experimental: Treatment IV Drug: DLBS-32
DLBS-32 300 mg once daily and lifestyle modification
Placebo Comparator: Placebo Drug: Placebo capsule
Placebo capsules once daily and lifestyle modification

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005069

Locations
Indonesia
Sanglah Hospital Denpasar
Denpasar, Bali, Indonesia
RSUD Tarakan
Jakarta Pusat, DKI Jakarta, Indonesia
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01005069     History of Changes
Other Study ID Numbers: DLBS-32-0309
Study First Received: October 28, 2009
Last Updated: September 26, 2010
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
diabetes mellitus
DLBS-32
fasting plasma glucose
insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014