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

NCT01005069 | Completed Phase 2

• 1 other identifier: DLBS-32-0309
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus; DLBS-32; fasting plasma glucose; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Reduction of venous Fasting Plasma Glucose from baseline

  every 2-week interval over 6 weeks of treatment

Secondary Outcomes (6)

• 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

Study Arms (5)

Treatment I

EXPERIMENTAL

Drug: DLBS-32

Treatment II

EXPERIMENTAL

Drug: DLBS-32

Treatment III

EXPERIMENTAL

Drug: DLBS-32

Treatment IV

EXPERIMENTAL

Drug: DLBS-32

Placebo

PLACEBO COMPARATOR

Drug: Placebo capsule

Interventions

DLBS-32 DRUG

DLBS-32 50 mg once daily and lifestyle modification

Treatment I

Placebo capsule DRUG

Placebo capsules once daily and lifestyle modification

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dexa Medica Group: lead

Study Sites (2)

Sanglah Hospital Denpasar

Denpasar, Bali, Indonesia

Location

RSUD Tarakan

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 28, 2010

Record last verified: 2010-09

Locations

ID (2)