Clinical trial NCT01531933: 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prediabetic
Keywords: Prediabetic
Primary prevention
Type 2 diabetes mellitus
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in 15-minute post prandial insulin level
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Change in 15-minute post prandial insulin level
timeFrame: 8 weeks of treatment
measure: Change in 2-hour post prandial insulin level
timeFrame: 8 weeks and 12 weeks of treatment
measure: Change in 15-minute post prandial plasma glucose
timeFrame: 8 weeks and 12 weeks of treatment
measure: Change in 2-hour post prandial plasma glucose
timeFrame: 4 weeks, 8 weeks, and 12 weeks of treatment
measure: Change in HOMA-IR
timeFrame: 8 weeks and 12 weeks of treatment
measure: Change in hs-CRP
timeFrame: 8 weeks and 12 weeks of treatment
measure: Improvement in lipid profile
timeFrame: 8 weeks and 12 weeks of treatment
measure: Change in adiponectin
timeFrame: 8 weeks and 12 weeks of treatment
measure: Change in waist-to-hip ratio
timeFrame: 4 weeks, 8 weeks, and 12 weeks of treatment
measure: ECG
timeFrame: 12 weeks of treatment
measure: Vital signs
timeFrame: 4 weeks, 8 weeks, and 12 weeks of treatment
measure: Body weight
timeFrame: 4 weeks, 8 weeks, and 12 weeks of treatment
measure: Liver function
timeFrame: 12 weeks of treatment
measure: Renal function
timeFrame: 12 weeks of treatment
measure: Adverse events
timeFrame: 1-12 weeks of treatment
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Department of Internal Medicine, dr. M. Djamil Padang Hospital
state: West Sumatera
Study officials:
affiliation: Department of Internal Medicine, dr. M. Djamil Padang Hospital
name: Asman Manaf, Prof., Dr., dr., SpPD-KEMD
role: PRINCIPAL_INVESTIGATOR
References: