Study to Assess the Effects of Deglusterol on Type 2 Diabetes Mellitus.
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 in Patients With Type 2 Diabetes Mellitus.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CG-D-P02, Version 2.0 dated 22/May/2023
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
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle, Ahmedabad, Gujarat 382210, India. S.G. Highway, Sarkhej Ahmadabad GUJARAT 382210 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
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle, Ahmedabad, Gujarat 382210, India. S.G. Highway, Sarkhej
GUJARAT 382210 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
TURQUOISE-IV 6th Floor, Sardar Patel Ring Rd, Opp. Apple Woods, Near Shantipura circle, Ahmedabad, Gujarat 382210, India. S.G. Highway, Sarkhej
GUJARAT 382210 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
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 = 5
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Mona Shah
Anand Multispeciality Hospital
-Tower, Sundarvan complex, Gorwa refinery rd, near Gorwa, beside IOCL petrol pump, Vadodara – 390016, Gujarat, India. Vadodara GUJARAT
9601987561
drmonashah.cr@gmail.com
Dr Jitendra Anand
Anand Multispeciality Hospital and Research Center
Plot No. 1180, Sector 3-D, Gandhinagar-382003, Gujarat, India. Gandhinagar GUJARAT
8780089653
parthpatel458@gmail.com
Dr Dharmendra Panchal
Prajna Health Care
205-208, 2nd floor, Aagam Avenue, Nr. Adani CNG pump, Acher sabarmati, Ahmedabad – 380005, Gujarat, India. Ahmadabad GUJARAT
9879204223
panchaldrd@gmail.com
Dr Dhaiwat Shukla
V. S. General Hospital
Madalpur Gam, Nr. Ellisbridge, Paldi, Ahmedabad – 380006, Gujarat, India. Ahmadabad GUJARAT
8980024107
dr.dhaiwatshukla89@gmail.com
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
Anand Ethics Committee
Approved
Anand Institutional Ethics Committee
Approved
Hitech Ethics Committee
Approved
Riddhi Medical Nursing Home IEC
Approved
Sangini Hospital Ethics Committe
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Deglusterol
Dose: 30 mg powdered Deglusterol ,
Frequency: Twice a day daily,
Route of Administration: Oral,
Duration of Therapy: 12 weeks.
Comparator Agent
Placebo
Dose:3,000 mg maltodextrin.
Frequency: Twice a day daily,
Route of Administration; Oral,
Duration of Therapy: 12 weeks.
Inclusion Criteria
Age From
20.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Males and females between 20 to 75 years of age (inclusive) of any ethnicity.
2. Subjects diagnosed with type 2 diabetes mellitus with HbA1c 6.5 to 11 percent and fasting plasma glucose level greater than 125 mg per dl.
3. Subjects who are on stable dose of Metformin for at least 4 weeks prior to screening and likely to receive the same dose of Metformin during the study.
4. Non-smoker.
5. Body mass index less than 35 kg per m2.
6. Vital signs are normal, or deemed abnormal but clinically insignificant by the Investigator.
7. Clinical laboratory evaluations (including clinical chemistry, hematology, and urine analysis) are normal or deemed clinically insignificant by the Investigator.
8. 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 9) or is not of child-bearing potential, the male is not required to be sterile or, if not sterile, to use an approved form of contraception.
9. Female subjects who are:
a. Postmenopausal (absence of menses for 1 year or more)
b. Surgically sterilized
c. WOCBP who are non-lactating 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 a concentration of at least 50 microgram of the estrogenic component of a biphasic or triphasic pill, transdermal, injectable, or implantable contraceptive; intrauterine device or intrauterine system or double-barrier method (eg. diaphragm and condom)). Abstinence is not considered an acceptable form of birth control).
d. WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study
10. 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. Perform light exercise daily for about 30 minutes.
d. Maintain their habitual diet and level of physical activity.
e. Fast for a minimum of 12 hours prior to each clinic visit.
11. Subjects who, during the investigative period, are not planning to participate in intense physical activity (eg. marathon).
12. Subjects who are capable of providing informed consent and complying with all study procedures or requirements.
ExclusionCriteria
Details
1. Use of hypoglycemic agents other than Metformin.
2. Currently or within last 12 weeks under insulin treatment at the time of screening
3. Use of frequent systemic glucocorticoids (greater than4 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 greater than2X the normal upper limit of the testing institution.
5. AST or ALT measure greater than3X the normal upper limit of the testing institution.
6. Upper limit of FBS ie. Greater than 300 mg per dL with severe clinical manifestations present (significant loss weight, severe symptoms and per or ketonuria).
7. Uncontrolled thyroid disease or hypertension (i.e., systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 100 mmHg).
8. 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.
9. Current use of medication or medical device treatment for schizophrenia, depression, drug addiction, or alcoholism.
10. Participation in clinical trials or human studies within 1 month of the start of this study and received other medicines or has applied other medical devices.
11. Person who is expected to receive other medicines or applied medical devices by participating in other clinical trials or human studies during the participation period in this study.
12. Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
13. Subjects who test positive at screening for recreational drugs or alcohol.
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 28, Day 56 & Day 84
Day 0,28, 56 & 84.
Secondary Outcome
Outcome
TimePoints
The secondary endpoints will be assessed at baseline (Day 0), Day 28, Day 56 & Day 84 & OGTT will be assessed only at Day 0 and Day 84
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
NA
Safety Endpoint:
Laboratory tests, Physical examination, vital signs, 12-Lead ECG, concomitant medications or combination treatments & adverse events (Time frame: Day 0, Day 28, Day 56 & Day 84)
Note: The laboratory tests (clinical chemistry, hematology and urine analysis [UA]) for safety assessment will be performed only at Day 0 and Day 84
Target Sample Size
Total Sample Size="80" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
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 80 male and female subjects, diagnosed with type 2 diabetes mellitus,
will be enrolled.
Subjects will be screened
according to the study inclusion and exclusion criteria 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 40 randomized subjects to get 70 evaluable subjects
(35 completed subjects in each arm) in the study. Recruitment may be stopped
after 70 evaluable subjects complete the study.