Skip to main content
OpenTrials
Completed

NCT Number: NCT01005069

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanglah Hospital Denpasar, Denpasar, Bali, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DLBS-32

Drug

DLBS-32 50 mg once daily and lifestyle modification

Placebo capsule

Drug

Placebo capsules once daily and lifestyle modification

Primary outcomes

  1. Reduction of venous Fasting Plasma Glucose from baseline

    Time frame: every 2-week interval over 6 weeks of treatment

Secondary outcomes

  1. Reduction of 2h-post-prandial plasma glucose from baseline

    Time frame: six weeks

  2. Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline

    Time frame: six weeks

  3. Change of high sensitivity C-reactive protein (hs-CRP) from baseline

    Time frame: six weeks

  4. Liver Function, Renal Function, Adverse events

    Time frame: six weeks

  5. Change in HbA1c from baseline

    Time frame: six weeks

  6. Change in lipid profile from baseline

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 30, 2009
Registry last updated
Sep 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.