Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular

NCT ID: NCT04141241

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-04
• Study Completion Date: 2018-05-04

Brief Summary

This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.

Detailed Description

After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100.

Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period.

Conditions

Type 2 Diabetes Mellitus With Circulatory Complciation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Low Dose PH100: 800mg/day

• PH100 (Ecklonia cava Phlorotannin) 200mg/tablet
• PH100 2 tablets (400mg) and Placebo 2 tablets BID during 12wks

Group Type: EXPERIMENTAL

Ecklonia cava Phlorotannin

Intervention Type: DRUG

Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.

High Dose PH100: 1600mg/day

\- PH100 4 tablets (800mg) BID during 12wks

Group Type: EXPERIMENTAL

Ecklonia cava Phlorotannin

Intervention Type: DRUG

Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.

Placebo

• Placebo 200mg/tablet
• Placebo 4 tablets BID during 12wks

Group Type: PLACEBO_COMPARATOR

Ecklonia cava Phlorotannin

Intervention Type: DRUG

Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.

Interventions

Ecklonia cava Phlorotannin

Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.

Intervention Type: DRUG

Other Intervention Names

PH100

Eligibility Criteria

Inclusion Criteria

1. Age >= 19 years old

2. Subjects who have been treated for cardiovascular complications (stent insertion due to angina pectoris, myocardial infarction, cerebral ischemia, peripheral vascular disease) within 4 weeks prior to baseline

3. T2DM patients who diagnosed with type 2 diabetes prior to or above cardiovascular complications and have been taking oral hypoglycemic agents and/or receiving insulin treatment before the above complication occurred

4. Subjects taking a stable dose of statins and are anticipated to have no change in dose during the duration of the study

5. The following is confirmed through screening:

• AST/ALT ≤ 2.5 X ULN
• Creatinine ≤ 1.5 X ULN
• Hemoglobin ≥ 10 g/dL
• 6.5% ≤ HbA1c ≤ 11%

6. Women of child-bearing potential who have negative pregnancy testing results and have agreed to use appropriate measures of contraception* during the duration of the study (*appropriate contraception is defined as women of child-bearing potential, excluding women in whom more than 52 weeks have passed since their last period, using the following methods: surgical sterilization, intrauterine device, condoms, barrier contraceptives, absolute abstinence)

7. Subjects who have signed the informed consent form (or whose legal representative has signed) and who are deemed to be able to follow the requirements of the study

Exclusion Criteria

1. T2DM patients, secondary DM patients, Gestational DM patients

2. Subjects who have a history of secondary hypertension or have a disease history of suspicious secondary hypertension. This includes but is not restricted to: aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.

3. Subjects taking anti-inflammatory agents including corticosteroids/NSAIDs (However, maximum 100mg of aspirin per day is allowed)

4. Subjects with chronic liver/renal disease or malignancy

5. Supplements containing kajime or kajime derivatives (e.g. Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus) and related medications, or subjects who have a history of hypersensitivity to high iodine containing products (seaweed, shellfish, etc.)

6. Pregnant, breast-feeding subjects or subjects who have plans for pregnancy

7. Subjects who have taken supplements containing kajime or kajime derivatives within 4 weeks of baseline (e.g., Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol- EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus)

8. Subjects who have participated in another clinical trial within 4 weeks of baseline and have taken other clinical trial medications

9. Subjects who have received treatment for or who test positive for HBsAg, HCV antibody, or HIV at baseline

10. Subjects who have an acute inflammatory disease other than cardiovascular complications within 4 weeks of baseline

11. Subjects who have gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of drugs (e.g. Crohn's disease) and subjects who have a history of gastrointestinal surgery (with the exception of appendectomy and hernia repair), or subjects with active gastritis, gastrointestinal/rectal bleeding, active inflammatory bowel disease within the past 12 months

12. Subjects with autoimmune disease (e.g. rheumatoid arthritis) or who require chronic anti-inflammatory treatment

13. Subjects with a history of drug or alcohol abuse

14. Subjects who are judged not to be appropriate for participation in the study or who have a medical condition that may have an influence on the study results

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bota Bio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BOTAB-DBCVC-PH100

Identifier Type: -

Identifier Source: org_study_id