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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014