Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors in type 2 diabetes mellitus patients who are on Metformin + gliptin combination therapy.
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 type 2 diabetes mellitus patients who are on Metformin + gliptin
combination therapy.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CG-D-P03, Version 1.0 dated 20/Jul/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
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
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
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
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Deglusterol
Dose: 1 sachet - 3,000 mg total Equal to 100 mg powdered Deglusterol,
Frequency:Twice a day daily, till 12 weeks,
Route of Administration:Oral,
Duration of Therapy:12 weeks.
Comparator Agent
Placebo
Dose: 1 sachet - 3,000 mg total Equal to 3,000 mg maltodextrin.
Frequency: Twice a day daily, till 12 weeks
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
Subjects will be considered eligible to participate in the study if they meet all the following inclusion criteria:
Inclusion Criteria
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 6.5Percent - 10Percent and fasting plasma glucose level greater than 125 mg per dl.
3. Subjects who are on same dose of Metformin and gliptin combination therapy for at least 8 weeks prior to screening and likely to receive the same dose of it during the study.
4. Non-smoker.
5. Body mass index 18 to 35 kg per m2 (both inclusive).
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 micro g of the estrogenic component of a biphasic or triphasic pill, transdermal, injectable, or implantable contraceptive, intrauterine device or intrauterine system or double-barrier method e.g., 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. Subject is on habitual diet and exercise program at least 8 weeks prior to study participation and expected to remain the same during the study
12. Subjects who, during the investigative period, are not planning to participate in intense physical activity (eg. marathon).
13. 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 combination therapy of Metformin and gliptin
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 within 3 months of screening.
4. A creatinine level greater than2X the normal upper limit of the testing institution.
5. AST or ALT measure greater than2X the normal upper limit of the testing institution.
6. Upper limit of FBS i.e. greater than 300 mg per dL with severe clinical manifestations present (significant loss weight, severe symptoms and 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.
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 28, Day 56 and Day 84
(Day 0), Day 28, Day 56 and Day 84
Secondary Outcome
Outcome
TimePoints
The secondary endpoints will be assessed at baseline (Day 0), Day 28, Day 56 and Day 84 and OGTT will be assessed only at Day 0 and Day 84
I. Fasting plasma insulin
ii. Fasting plasma HbA1c
iii. HOMA-IR, HOMA-β, and QUICKI values
iv. Blood lipids and lipoproteins (i.e., TG, TC, HDL-C, LDL-C, Lp[a], ApoA1, ApoB)
v. Blood C-peptide
vi. Blood pressure
vii. Body weight
viii. Body fat mass
ix. Plasma glucose levels 1 and 2 hours following an OGTT
NA
Laboratory tests, Physical examination, vital signs, 12-Lead ECG, concomitant medications or combination treatments and adverse events (Time frame: Day 0, Day 28, Day 56 and 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
patients who are on Metformin + gliptin combination therapy 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.