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CTRI Number  CTRI/2023/01/048723 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 28/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors. 
Scientific Title of Study   A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
CG-D-P01 Version 2.0 dated 23/Nov/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej

Ahmadabad
GUJARAT
380054
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej


GUJARAT
380054
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Vice President - Clinical Operations 
Affiliation  CBCC Global Research 
Address  2nd Floor, Skoda House, Opp. LJ Campus, S.G. Highway, Sarkhej


GUJARAT
380054
India 
Phone  9637555304  
Fax    
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Caregen Co., Ltd., Building, 46-38, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea 14119  
 
Primary Sponsor  
Name  Caregen Co., Ltd. 
Address  Building, 46-38, LS-ro 91beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea 14119 Tel No: 031-420-9200 Phone: 031-420-9200 Fax: 031-452-3869  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jitendra Anand  Anand Multispeciality Hospital & Research Center  4th floor Sarthak Mall Mahatma Mandir Road Sargasan Cross Road Gandhinagar- 382421 Gujarat, India
Gandhinagar
GUJARAT 		 9824517101

jkanand09@gmail.com 
Dr Banshi Saboo  Dia Care Research  1-2, Gandhi Park, Near Nehrunagar Road, Ambawadi, Ahmedabad-380015, Gujarat, India
Ahmadabad
GUJARAT 		 9824047676

banshisaboo@hotmail.com 
Dr Parth Patel  Hi Tech Multispeciality Hospital  Sector 3D, Plot No. 1180, Near Gh 1½ Bus Stand, Gandhinagar - 382003, Gujarat, India
Gandhinagar
GUJARAT 		 8780089653

patelparth458@gmail.com 
Dr Manish Agarwal  Medilink Hospital Research Centre  Medilink Hospital, Near Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad- 380015, Gujarat, India.
Ahmadabad
GUJARAT 		 9825443397

medilinkhospital@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Anand Ethics committee  Approved 
Hi-Tech Ethics Committee   Approved 
Medilink Ethics Committee, Medilink Hospital  Approved 
Shrey Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R739||Hyperglycemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deglusterol Powder 3000 mg/100 mL (30 mg/mL) Caregen Co., Ltd.  Dosage: 3000 mg per 100 mL (30 mg per mL) Route of Administration: Oral Duration of Therapy: 28 days Frequency: Twice a day for 28 days  
Comparator Agent  Placebo  Dosage: 3,000 mg maltodextrin, Route of Administration: Oral, Duration of Therapy: 28 days, Frequency: Twice a day for 28 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects will be considered eligible to participate in the study if they meet all the following
inclusion criteria
1. Males and females between 20 to 75 years of age (inclusive) of any ethnicity.
2. One who satisfies at least one of the following prediabetic criteria
a. IFG A fasting blood glucose of 100 mg per dL and 125 mg per dL
b. Prediabetes HbA1c between 5.7 percent and 6.4 percent
3. Non-smoker.
4. Body mass index less than35 kg per m2.
5. Vital signs are normal, or deemed abnormal but clinically insignificant by the Investigator.
6. Clinical laboratory evaluations including clinical chemistry, hematology, and UA are normal or deemed clinically insignificant by the Investigator.
7. Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method (diaphragm, cervical cap, or condom) plus a contraceptive jelly spermicidal foam, gel, film, cream, or suppository. If the female sexual partner of the male is using an approved form of contraception (see inclusion criterion 8) or is not of childbearing potential, the male is not required to be sterile or if not sterile, to use an approved form of contraception.
8. Female subjects who are postmenopausal (absence of menses for 1 year or more), women who are surgically sterilized, or women of child-bearing potential who are nonlactating and have been using an effective form of birth control for a minimum of 6 months
prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period (effective forms of birth control include oral pills with concentration of at least 50 µg of the estrogenic component of a biphasic or triphasic pill; transdermal, injectable, or implantable contraceptive intrauterine device per intrauterine system or double-barrier method (for example diaphragm and condom). Abstinence is not considered an acceptable form of birth control. WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study.
9. Subjects who, during the investigative period, are willing to
a. Consume the prescribed test products.
b. Avoid physical activity for at least 12 hours prior to each clinic visit.
c. Maintain their habitual diet and level of physical activity.
d. Fast for a minimum of 12 hours prior to each clinic visit.
10. Subjects who, during the investigative period, are not planning to participate in intense physical activity (for example marathon).
11. Subjects who are capable of providing informed consent and complying with all study procedures per requirements.
 
 
ExclusionCriteria 
Details  Subjects will be considered ineligible to participate in the study if they meet one or more of the following exclusion criteria:
1. A diagnosis of diabetes.
2. Use of hypoglycemic agents (e.g., sulfonylurea, non-sulfonylurea, biguanide, a-glucosidase inhibitor, thiazolidinedione, GLP-1 agonist, DPP4 inhibitor, insulin) or other therapies, such as medicinal herbs, that may aid in the reduction of blood glucose or insulin.
3. Use of frequent systemic glucocorticoids (>4 courses), or growth hormone, or had a transplant of any type or cystic fibrosis or any other therapy or current use of any medication which causes rise in plasma glucose level.
4. A creatinine level >2X the normal upper limit of the testing institution.
5. AST or ALT measure >3X the normal upper limit of the testing institution.
6. Uncontrolled thyroid disease or hypertension (i.e., systolic blood pressure 160 mmHg and/or diastolic blood pressure greater than or equal to100 mmHg).
7. Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment) within 6 months of the test or any other disease.
8. Current use of medication or medical device treatment for schizophrenia, depression, drug addiction, or alcoholism.
9. Participation in clinical trials/human studies within 1 month of the start of this study and received other medicines or has applied other medical devices.
10. Person who is expected to receive other medicines or applied medical devices by participating in other clinical trials/human studies during the participation period in this study.
11. Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
12. Subject who resides in the same household as another subject already participating in the study.
13. Subjects who test positive at screening for recreational drugs/alcohol.
14. Subjects who have any condition or showing symptoms of a condition that would make them, in the opinion of the Investigator, unsuitable for the study.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Fasting plasma glucose will be assessed at baseline (Day 0), Day 14 and Day 28  Day 0, 14 & 28. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints will be assessed at baseline (Day 0), Day 14 and Day 28 and OGTT will be assessed only at Day 0 and Day 28
Fasting plasma insulin;
Fasting plasma HbA1c;
HOMA-IR, HOMA-Beta, and QUICKI values;
Blood lipids and lipoproteins (i.e., TG, TC, HDL-C, LDL-C, Lp[a], ApoA1, ApoB);
Blood C-peptide,
Blood pressure;
Body weight;
Body fat mass;
Plasma glucose levels 1 and 2 hours following an OGTT;
 		 Timepoints: Day 0, 14 & 28.

 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The clinical trial is a randomized, double-blinded, placebo-controlled, parallel, multi-center study. A total of 70 male and female subjects, diagnosed with prediabetes (ages 20 to 75 years, inclusive), will be enrolled.

 

On the first day of the 4-week screening period3 (Day -28), subjects will be screened according to the study inclusion and exclusion criteria. Male subjects can be screened within 4 weeks prior to randomization (Day 0). Subjects meeting all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. Subjects who provide written informed consent to participate in the study will be randomized either to the Deglusterol group or the placebo group in a 1:1 ratio. Each group will consist of 35 subjects.

 

On the day of randomization (Day 0), blood samples for the assessment of primary and secondary outcomes will be collected (i.e., as baseline measures) and an OGTT will be conducted. Subjects will be asked to return 2 and 4 weeks after the baseline visit. Therefore, each subject will be required to make a total of 4 visits to the clinical research site (i.e., Days -28, 0, 14, and 28).

 

The study will commence only after obtaining written approval from the site Institutional Ethics Committee.

 
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