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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005069
• Other study ID #: DLBS-32-0309
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2009
• Last updated: September 26, 2010
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• DLBS-32
DLBS-32 50 mg once daily and lifestyle modification
• DLBS-32
DLBS-32 100 mg once daily and lifestyle modification
• DLBS-32
DLBS-32 200 mg once daily and lifestyle modification
• DLBS-32
DLBS-32 300 mg once daily and lifestyle modification
• Placebo capsule
Placebo capsules once daily and lifestyle modification

Locations

Country	Name	City	State
Indonesia	Sanglah Hospital Denpasar	Denpasar	Bali
Indonesia	RSUD Tarakan	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of venous Fasting Plasma Glucose from baseline		every 2-week interval over 6 weeks of treatment	No
Secondary	Reduction of 2h-post-prandial plasma glucose from baseline		six weeks	No
Secondary	Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline		six weeks	No
Secondary	Change of high sensitivity C-reactive protein (hs-CRP) from baseline		six weeks	No
Secondary	Liver Function, Renal Function, Adverse events		six weeks	Yes
Secondary	Change in HbA1c from baseline		six weeks	No
Secondary	Change in lipid profile from baseline		six weeks	No