DLBS1449 in Diabetic Patients With Low HDL

Diabetic Patients Clinical Trial

Official title:

The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01972477
• Other study ID #: DLBS1449-0111
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 24, 2013
• Last updated: August 3, 2016
• Start date: July 2016
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: Dexa Medica Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Patients
• Lifestyle Intervention for at Least 1 Month
• Low HDL-cholesterol (< 35 mg/dL)

Intervention

Drug:
• DLBS1449
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.

Other:
• Placebo
Placebo will be given every day for 8 weeks.

Locations

Country	Name	City	State
Indonesia	Surabaya Diabetes and Nutrition Center, Dr. Soetomo Hospital; Pusat Diagnostik Terpadu Building 7th Floor	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
Dexa Medica Group

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in HDL-cholesterol level		8 weeks	No
Secondary	Percent change in HDL-cholesterol level		4 and 8 weeks	No
Secondary	Percent change in LDL-cholesterol level		4 and 8 weeks	No
Secondary	Percent change in sd LDL-cholesterol level		4 and 8 weeks	No
Secondary	Percent change in triglycerides level		4 and 8 weeks	No
Secondary	Percent change in total cholesterol level		4 and 8 weeks	No
Secondary	Change in Apo-A1		4 and 8 weeks	No
Secondary	Change in Apo-B		4 and 8 weeks	No
Secondary	Response rate	Response rate is defined as percentage of subjects with HDL-cholesterol >= 40 mg/dL after 8 weeks of treatment.	8 weeks	No
Secondary	Change in A1c level		8 weeks	No
Secondary	Vital signs	Vital signs measurements include: blood pressure, heart rate, and respiratory rate.	4 and 8 weeks	Yes
Secondary	Routine hematology	Routine hematology measurements include: hemoglobin, hematocrit, RBC, WBC, differentiation of WBC, and platelet count.	4 and 8 weeks	Yes
Secondary	Liver function	Liver function measurements include: serum ALT, serum AST, gamma-GT, and alkaline phosphatase.	4 and 8 weeks	Yes
Secondary	Renal function	Renal function measurement includes: serum creatinine.	4 and 8 weeks	Yes
Secondary	Electrocardiography (ECG)	The interpretation of ECG result will be recorded. Any worsened changes from baseline condition will be counted as adverse events.	8 weeks	Yes
Secondary	Adverse event	Adverse event will be observed and recorded during the study period.	1-8 weeks	Yes