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.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/01/062047
- Lead Sponsor
- Caregen Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting plasma glucose will be assessed at baseline (Day 0), Day 28, Day 56 and Day 84Timepoint: (Day 0), Day 28, Day 56 and Day 84
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>I. Fasting plasma insulin <br/ ><br>ii. Fasting plasma HbA1c <br/ ><br>iii. HOMA-IR, HOMA-ß, and QUICKI values <br/ ><br>iv. Blood lipids and lipoproteins (i.e., TG, TC, HDL-C, LDL-C, Lp[a], ApoA1, ApoB) <br/ ><br>v. Blood C-peptide <br/ ><br>vi. Blood pressure <br/ ><br>vii. Body weight <br/ ><br>viii. Body fat mass <br/ ><br>ix. Plasma glucose levels 1 and 2 hours following an OGTT <br/ ><br>Timepoint: NA <br/ ><br>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) <br/ ><br>Note: The laboratory tests (clinical chemistry, hematology and urine analysis [UA]) for safety assessment will be performed only at Day 0 and Day 84 <br/ ><br>