Efficacy and Safety of DLBS3233 in Prediabetic Patients (DIPPER-DM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexa Medica Group
ClinicalTrials.gov Identifier:
NCT01531933
First received: February 9, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Prediabetic
Drug: DLBS3233
Drug: Placebo of DLBS3233
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]

Resource links provided by NLM:


Further study details as provided by Dexa Medica Group:

Primary Outcome Measures:
  • Change in 15-minute post prandial insulin level [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in 15-minute post prandial insulin level from baseline to 12 weeks of treatment


Secondary Outcome Measures:
  • Change in 15-minute post prandial insulin level [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
    Change in 15-minute post prandial insulin level from baseline to 8 weeks of treatment

  • Change in 2-hour post prandial insulin level [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in 2-hour post prandial insulin level from baseline to 8 weeks and to 12 weeks of treatment

  • Change in 15-minute post prandial plasma glucose [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in 15-minute post prandial plasma glucose from baseline to 8 weeks and to 12 weeks of treatment

  • Change in 2-hour post prandial plasma glucose [ Time Frame: 4 weeks, 8 weeks, and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in 2-hour post prandial plasma glucose from baseline to each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  • Change in HOMA-IR [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in HOMA-IR from baseline to 8 weeks and to 12 weeks of treatment

  • Change in hs-CRP [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in hs-CRP from baseline to 8 weeks and to 12 weeks of treatment

  • Improvement in lipid profile [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    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

  • Change in adiponectin [ Time Frame: 8 weeks and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in adiponectin from baseline to 8 weeks and to 12 weeks of treatment

  • Change in waist-to-hip ratio [ Time Frame: 4 weeks, 8 weeks, and 12 weeks of treatment ] [ Designated as safety issue: No ]
    Change in waist-to-hip ratio from baseline to each of study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  • ECG [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    ECG will be evaluated at baseline and at end of study (12 weeks of treatment)

  • Vital signs [ Time Frame: 4 weeks, 8 weeks, and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    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)

  • Body weight [ Time Frame: 4 weeks, 8 weeks, and 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Body weight will be evaluated at baseline and at each study visit (4 weeks, 8 weeks, and 12 weeks of treatment)

  • Liver function [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Liver function (levels of serum ALT, γ-GT, alkaline phosphatase) will be evaluated at baseline and at end of study (12 weeks of treatment)

  • Renal function [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
    Renal function (serum creatinine level) will be evaluated at baseline and at end of study (12 weeks of treatment)

  • Adverse events [ Time Frame: 1-12 weeks of treatment ] [ Designated as safety issue: Yes ]
    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


Enrollment: 80
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DLBS3233 Drug: DLBS3233
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 Name: Inlacin
Placebo Comparator: Placebo of DLBS3233 Drug: Placebo of DLBS3233
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531933

Locations
Indonesia
Department of Internal Medicine, dr. M. Djamil Padang Hospital
Padang, West Sumatera, Indonesia
Sponsors and Collaborators
Dexa Medica Group
Investigators
Principal Investigator: Asman Manaf, Prof., Dr., dr., SpPD-KEMD Department of Internal Medicine, dr. M. Djamil Padang Hospital
  More Information

No publications provided

Responsible Party: Dexa Medica Group
ClinicalTrials.gov Identifier: NCT01531933     History of Changes
Other Study ID Numbers: DLBS3233-0711
Study First Received: February 9, 2012
Last Updated: August 6, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Dexa Medica Group:
Prediabetic
Primary prevention
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014