Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
This study has been completed.
Sponsor:
Dexa Medica Group
Information provided by:
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01005069
First received: October 28, 2009
Last updated: September 26, 2010
Last verified: September 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 22, 2013