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Completed

NCT Number: NCT01531933

Efficacy and Safety of DLBS3233 in Prediabetic Patients

This is a 2-arm, prospective, double blind, randomized, and controlled clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of DLBS3233.

It is hypothesized that DLBS3233 will delay the progress of beta-cell dysfunction as measured by the improvement of prandial (particularly the first phase) insulin secretion as well as insulin resistance in prediabetic subjects which may prevent the conversion of prediabetes into type 2 diabetes mellitus.

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Key information

Conditions

Prediabetic Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Internal Medicine, dr. M. Djamil Padang Hospital

Padang, West Sumatera, Indonesia

About this study

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 for 12 weeks of therapy.

Subjects will be provided with an education on lifestyle modification given by the assigned nutritionist. All subjects will be advised to follow such a lifestyle modification throughout the study period.

All subjects will be under direct supervision of a medical doctor during the study period.

All clinical and laboratory examinations to evaluate the investigational drug's efficacy, will be performed at baseline, Week 8th and Week 12th (end) of study treatment. Blood glucose level (both FPG and 2h-PG) will be performed at baseline and at interval of 4 weeks over the 12 weeks of study treatment. Safety examinations will be performed at baseline and at the end of study. Occurrence of adverse event will be observed during the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female subjects with age of 18-60 years
  • Prediabetic patients (2h-PPPG level of 140-199 mg/dL)
  • Serum ALT ≤ 2.5 times upper limit of normal
  • Serum creatinine < 1.5 times upper limit of normal
  • Able to take oral medication

Exclusion criteria

  • Female of childbearing potential
  • History of diabetes mellitus
  • History of symptomatic coronary arterial disease, stroke, and cardiovascular events
  • 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

For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

Other names: Inlacin

Placebo of DLBS3233

Drug

For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.

Primary outcomes

  1. Change in 15-minute post prandial insulin level

    Time frame: 12 weeks of treatment

    Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment

Secondary outcomes

  1. Change in 15-minute post prandial insulin level

    Time frame: 8 weeks of treatment

    Change in 15-minute post prandial insulin level from baseline to 8 weeks of treatment

  2. Change in 2-hour post prandial insulin level

    Time frame: 8 weeks and 12 weeks of treatment

    Change in 2-hour post prandial insulin level from baseline to 8 weeks and to 12 weeks of treatment

  3. Change in 15-minute post prandial plasma glucose

    Time frame: 8 weeks and 12 weeks of treatment

    Change in 15-minute post prandial plasma glucose from baseline to 8 weeks and to 12 weeks of treatment

  4. Change in 2-hour post prandial plasma glucose

    Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment

    Change in 2-hour post prandial plasma glucose from baseline to each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  5. Change in HOMA-IR

    Time frame: 8 weeks and 12 weeks of treatment

    Change in HOMA-IR from baseline to 8 weeks and to 12 weeks of treatment

  6. Change in hs-CRP

    Time frame: 8 weeks and 12 weeks of treatment

    Change in hs-CRP from baseline to 8 weeks and to 12 weeks of treatment

  7. Improvement in lipid profile

    Time frame: 8 weeks and 12 weeks of treatment

    Improvement in lipid profile from baseline to 8 weeks and to 12 weeks of treatment, including: fasting plasma HDL-cholesterol, fasting plasma triglyceride, 15-minute post prandial plasma triglyceride, and 2-hour post prandial plasma triglyceride

  8. Change in adiponectin

    Time frame: 8 weeks and 12 weeks of treatment

    Change in adiponectin from baseline to 8 weeks and to 12 weeks of treatment

  9. Change in waist-to-hip ratio

    Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment

    Change in waist-to-hip ratio from baseline to each of study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  10. ECG

    Time frame: 12 weeks of treatment

    ECG will be evaluated at baseline and at end of study (12 weeks of treatment)

  11. Vital signs

    Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment

    Vital signs (systolic and diastolic blood pressure, heart rate, respiration rate) will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  12. Body weight

    Time frame: 4 weeks, 8 weeks, and 12 weeks of treatment

    Body weight will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  13. Liver function

    Time frame: 12 weeks of treatment

    Liver function (levels of serum ALT, γ-GT, alkaline phosphatase) will be evaluated at baseline and at end of study (12 weeks of treatment)

  14. Renal function

    Time frame: 12 weeks of treatment

    Renal function (serum creatinine level) will be evaluated at baseline and at end of study (12 weeks of treatment)

  15. Adverse events

    Time frame: 1-12 weeks of treatment

    Adverse events as well as number of subjects experienced the events will be observed and evaluated during 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

Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]

Acronym: DIPPER-DM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2012
Registry last updated
Aug 7, 2012

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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