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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo capsule; Drug: DLBS-32

• Registration Number: NCT01005069
• Lead Sponsor: Dexa Medica Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-26
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo capsule	-
Treatment I	DLBS-32	-
Treatment III	DLBS-32	-
Treatment II	DLBS-32	-
Treatment IV	DLBS-32	-

Primary Outcome Measures

Name	Time	Method
Reduction of venous Fasting Plasma Glucose from baseline	every 2-week interval over 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Reduction of 2h-post-prandial plasma glucose from baseline	six weeks
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline	six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline	six weeks
Liver Function, Renal Function, Adverse events	six weeks
Change in HbA1c from baseline	six weeks
Change in lipid profile from baseline	six weeks

Trial Locations

Locations (2)

RSUD Tarakan; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia

Sanglah Hospital Denpasar; 🇮🇩 Denpasar, Bali, Indonesia