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

• ClinicalTrials.gov Identifier: NCT01531933
• Recruitment Status: Completed
• First Posted: February 13, 2012
• Last Update Posted: August 7, 2012
• Sponsor: Dexa Medica Group
• Information provided by (Responsible Party): Dexa Medica Group

Tracking Information

• First Submitted Date: February 9, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: August 7, 2012
• Study Start Date: November 2011
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 9, 2012)

• 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
• 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
• 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
• 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)
• 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
• 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
• 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
• 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
• 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)
• ECG [ Time Frame: 12 weeks of treatment ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of DLBS3233 in Prediabetic Patients
• Official Title: Phase III Clinical Study : DLBS3233 in Primary Prevention of Type 2 Diabetes Mellitus [DIPPER-DM]

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Prediabetic

Intervention

• 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
• 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.

Study Arms

• Experimental: DLBS3233
  Intervention: Drug: DLBS3233
• Placebo Comparator: Placebo of DLBS3233
  Intervention: Drug: Placebo of DLBS3233

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2012): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT01531933
• Other Study ID Numbers: DLBS3233-0711
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dexa Medica Group
• Study Sponsor: Dexa Medica Group
• Collaborators: Not Provided

Investigators

• Principal Investigator: Asman Manaf, Prof., Dr., dr., SpPD-KEMD; Department of Internal Medicine, dr. M. Djamil Padang Hospital

• PRS Account: Dexa Medica Group
• Verification Date: August 2012