DLBS1449 in Diabetic Patients With Low HDL
3 augusti 2016 uppdaterad av: Dexa Medica Group
The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL) cholesterol in diabetic patients.
The hypothesis of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo.
In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
There will be three groups of treatment by dosage regimen in this study.
Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1449 at a dose of 1 x 75 mg daily, or 2) DLBS1449 at a dose of 1 x 150 mg (two capsules of DLBS1449 75 mg) daily; or 3) placebo, once daily.
Study medication should be administered once daily, in the evening with meal, for eight weeks.
Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at interval of four weeks over 8-week course of therapy.
Studietyp
Interventionell
Fas
- Fas 2
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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East Java
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Surabaya, East Java, Indonesien
- Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Male or female 21 - 70 years.
- Have been diagnosed diabetes mellitus and being treated with lifestyle intervention for at least 1 month prior to screening, with or without antidiabetic agents.
- HDL-cholesterol level of < 35 mg/dL.
- Triglycerides level of < 200 mg/dL.
- Adequate liver and renal function.
- Statin and/or fenofibrate therapy should have been being regularly taken for >=3 months at stable dose (ONLY for subjects currently under statin and/or fenofibrate therapy).
- Able to take oral medication.
Exclusion Criteria:
- Pregnant or breast-feeding women or willing to be pregnant.
- Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg).
- Any other disease state, including chronic/acute systemic infections, uncontrolled illnesses or other chronic diseases, which judged by the investigator, could interfere with trial participation or trial evaluation.
- Concurrent treatment with systemic corticosteroids or herbal (alternative) medicines.
- Known allergic or hypersensitive to drugs contain similar active substance with the study medication.
- Participation in any other clinical studies within 30 days prior to screening.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: DLBS1449, 1x75 mg
DLBS1449 softcapsule 1x75 mg daily, taken every day along the study period.
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Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily.
DLBS1449 will be given every day for 8 weeks.
Andra namn:
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Experimentell: DLBS1449, 1x150 mg
DLBS1449 softcapsule 1x150 mg (2 softcapsules 75 mg) daily, taken every day along the study period
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Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily.
DLBS1449 will be given every day for 8 weeks.
Andra namn:
|
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Placebo-jämförare: Placebo
Placebo once daily, taken every day along the study period
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Placebo will be given every day for 8 weeks.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percent change in HDL-cholesterol level
Tidsram: 8 weeks
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8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent change in HDL-cholesterol level
Tidsram: 4 and 8 weeks
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4 and 8 weeks
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Percent change in LDL-cholesterol level
Tidsram: 4 and 8 weeks
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4 and 8 weeks
|
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Percent change in sd LDL-cholesterol level
Tidsram: 4 and 8 weeks
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4 and 8 weeks
|
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Percent change in triglycerides level
Tidsram: 4 and 8 weeks
|
4 and 8 weeks
|
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Percent change in total cholesterol level
Tidsram: 4 and 8 weeks
|
4 and 8 weeks
|
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Change in Apo-A1
Tidsram: 4 and 8 weeks
|
4 and 8 weeks
|
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Change in Apo-B
Tidsram: 4 and 8 weeks
|
4 and 8 weeks
|
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Response rate
Tidsram: 8 weeks
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Response rate is defined as percentage of subjects with HDL-cholesterol >= 40 mg/dL after 8 weeks of treatment.
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8 weeks
|
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Change in A1c level
Tidsram: 8 weeks
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8 weeks
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Vital signs
Tidsram: 4 and 8 weeks
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Vital signs measurements include: blood pressure, heart rate, and respiratory rate.
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4 and 8 weeks
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Routine hematology
Tidsram: 4 and 8 weeks
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Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.
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4 and 8 weeks
|
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Liver function
Tidsram: 4 and 8 weeks
|
Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.
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4 and 8 weeks
|
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Renal function
Tidsram: 4 and 8 weeks
|
Renal function measurement includes: serum creatinine.
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4 and 8 weeks
|
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Electrocardiography (ECG)
Tidsram: 8 weeks
|
The interpretation of ECG result will be recorded.
Any worsened changes from baseline condition will be counted as adverse events.
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8 weeks
|
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Adverse event
Tidsram: 1-8 weeks
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Adverse event will be observed and recorded during the study period.
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1-8 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD, Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2016
Primärt slutförande (Förväntat)
1 oktober 2017
Avslutad studie (Förväntat)
1 januari 2018
Studieregistreringsdatum
Först inskickad
24 oktober 2013
Först inskickad som uppfyllde QC-kriterierna
24 oktober 2013
Första postat (Uppskatta)
30 oktober 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- DLBS1449-0111
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