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Completed

NCT Number: NCT01472614

Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

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Key information

Conditions

Type-2 Diabetes Mellitus

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Private Clinic at Jl. Prof. Dr. Moestopo 164, Surabaya, East Java, Indonesia

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About this study

There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening
  • Diagnosed with type-2 diabetes mellitus
  • Have been being treated with a combination of two OHA for at least 3 months prior to screening
  • A1c level of >= 7.0 %
  • Hemoglobin level of >= 10 g/dL
  • Body Mass Index (BMI) > 18.5 kg/m2
  • Refuse insulin therapy
  • Able to take oral medicine

Exclusion criteria

  • Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg
  • History of or current chronic treatment with insulin
  • History of renal and/or liver disease
  • Impaired liver function: serum ALT > 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test
  • Impaired renal function: serum creatinine >= 1.5 times upper limit of normal
  • Current treatment with systemic corticosteroids or herbal (alternative) medicines
  • Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation
  • Participation in any other clinical studies within 30 days prior to screening

Treatment and study plan

DLBS3233

Drug

Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)

Other names: Inlacin

Primary outcomes

  1. Reduction of A1c level

    Time frame: 12 weeks

    Reduction of A1c level from baseline after 12 weeks of treatment

Secondary outcomes

  1. Reduction of venous A1c level

    Time frame: 6 weeks

    Reduction of venous A1c level from baseline to 6 weeks of treatment

  2. Reduction of venous FPG

    Time frame: 6 and 12 weeks

    Reduction of venous FPG from baseline to every evaluation-time point

  3. Reduction of venous 1h-PG

    Time frame: 6 and 12 weeks

    Reduction of venous 1 hour-post prandial plasma glucose from baseline to every evaluation-time point

  4. Change in fasting insulin level

    Time frame: 6 and 12 weeks

    Change in fasting insulin level from baseline to every evaluation-time point

  5. Change in HOMA-R

    Time frame: 6 and 12 weeks

    Change in HOMA-R from baseline to every evaluation-time point

  6. Change in HOMA-B

    Time frame: 6 and 12 weeks

    Change in HOMA-B from baseline to every evaluation-time point

  7. Change in adiponectin level

    Time frame: 6 and 12 weeks

    Change in adiponectin level from baseline to every evaluation-time point

  8. Change in lipid profile

    Time frame: 6 and 12 weeks

    Change in lipid profile from baseline to every evaluation-time point, including: LDL-cholesterol (direct), HDL-cholesterol, total cholesterol, and triglycerides

  9. Change in body weight

    Time frame: 6 and 12 weeks

    Change in body weight from baseline to every evaluation-time point

  10. Hematology

    Time frame: 6 and 12 weeks

    Hematology parameters (Hemoglobin level, Hematocrit, Red Blood Cell count, White Blood Cell count as well as its differentials, and platelet count) will be evaluated at baseline, at interval of 6 weeks, and at the end of study

  11. Liver function

    Time frame: 6 and 12 weeks

    Liver function parameters (serum ALT, serum AST, gamma-glutamyl transferase, alkaline phosphatase, and total bilirubin levels) will be measured at baseline, at interval of 6 weeks, and at the end of study

  12. Renal function

    Time frame: 6 and 12 weeks

    Renal function parameter, i.e. serum creatinine level will be measured at baseline, at interval of 6 weeks, and at the end of study

  13. Adverse events

    Time frame: 1-12 weeks

    Adverse events as well as number of subjects experienced the events will be observed and evaluated during the study period (12 weeks) and until all adverse events have been recovered or stabilized.

Sponsors and collaborators

Lead sponsor

Dexa Medica Group

Industry

Registry information

Official study title

Effect of Add-on Therapy With DLBS3233 on Glycemic Control, Lipid Profile, and Adiponectin in Patients With Type-2 Diabetes Mellitus

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2011
Registry last updated
May 27, 2013

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.

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