DLBS1449 in Diabetic Patients With Low HDL
3. august 2016 oppdatert 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).
Studieoversikt
Status
Tilbaketrukket
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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East Java
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Surabaya, East Java, Indonesia
- Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percent change in HDL-cholesterol level
Tidsramme: 8 weeks
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8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent change in HDL-cholesterol level
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Percent change in LDL-cholesterol level
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Percent change in sd LDL-cholesterol level
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Percent change in triglycerides level
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Percent change in total cholesterol level
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Change in Apo-A1
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Change in Apo-B
Tidsramme: 4 and 8 weeks
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4 and 8 weeks
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Response rate
Tidsramme: 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
Tidsramme: 8 weeks
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8 weeks
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Vital signs
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 and 8 weeks
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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
Tidsramme: 4 and 8 weeks
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Renal function measurement includes: serum creatinine.
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4 and 8 weeks
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Electrocardiography (ECG)
Tidsramme: 8 weeks
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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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Askandar Tjokroprawiro, Prof, SpPD, K-EMD, FINASIM, MD, Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2016
Primær fullføring (Forventet)
1. oktober 2017
Studiet fullført (Forventet)
1. januar 2018
Datoer for studieregistrering
Først innsendt
24. oktober 2013
Først innsendt som oppfylte QC-kriteriene
24. oktober 2013
Først lagt ut (Anslag)
30. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- DLBS1449-0111
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