Efficacy and Safety of DLBS3233 in Prediabetic Patients - Full Text View

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Pre-diabetes

U.S. FDA Resources

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.

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

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 June 17, 2013

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