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

Dexa Medica

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: DLBS-32; Drug: Placebo capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005069

DLBS-32-0309

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 5 patient groups, including a placebo group

Treatment I

Experimental group

Treatment:

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Treatment II

Experimental group

Treatment:

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Treatment III

Experimental group

Treatment:

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Treatment IV

Experimental group

Treatment:

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Drug: DLBS-32

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo capsule