SWD 21787-21787x

Stipend and Dates

Up to $23,100.

All dates & times are tentative and may change.	Cohort 1a
Day -2 Admit	Jan 03, 2024
Day 45 Discharge	Feb 18, 2024
Day 73 Phone call	Mar 17, 2024

 

Click here to make an appointment for SWD 21787-21787x Type 2 Diabetics Only

Or call 210-225-5437 for more information

 

Study Criteria

Adults with Type 2 Diabetes for at least 6 months

On stable dose of Metformin for at least 3 months

No other antidiabetic medications in last 3 months

A1c of 6.5% to 8.5%

Fully vaccinated for COVID-19. Must show proof.

Non-Smokers

Age:  18-55

BMI:  25.0 to 40.0 kg/m2    

 

Study Information

Indication: The investigational drug is being developed as a possible treatment of Type 2 Diabetes

Route of Administration: Oral

Washout from previous study: Participation in a clinical study and received treatment within 30 days prior to screening.

 

All females subjects must have a negative pregnancy test at screening and must not be pregnant, lactating or of childbearing potential. Non-childbearing potential is defined as:

• Females post hysterectomy, bilateral oophorectomy or bilateral tubal ligation.
• Postmenopausal females: defined as at least 12 months of amenorrhea in women over age 45 years in the absence of other biological or physiological causes, prior to screening, and a serum FSH level >40 mIU/ml in women under the age of 55 years.  Female subjects without a record of non-childbearing potential (provided by a subject during medical history interview) or appropriate FSH levels (measure at screening) will be excluded.

 

Male subjects must be surgically sterile, abstinent, or if engaged in sexual relations with women of childbearing potential, the subject and his partner must use 2 acceptable methods of contraception, 1 of which must be a barrier method, during the study, and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and occlusive cap (diaphragm or cervical caps).  Acceptable nonbarrier forms of contraception for this study are hormonal contraception, intrauterine device, bilateral tubal ligation, and/or spermicide.  Subject’s female partners using hormonal contraceptives must be on a stable regimen for one ovulatory cycle, prior to screening.  Total abstinence, in accordance with the lifestyle of the subject, is also acceptable.

 

Male subjects must not donate sperm from the admission to the clinical research center until 90 days after the last dose of study drug.

           

Study Reminders

• 10 hours fasting is required for lab work (only water is allowed)
• If taking medications, bring them to your screening appointment (including prescription, over the counter, herbal supplements and vitamins)
• Bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a valid government issued identification card such as a driver's license, state issued ID card or passport.  You will be required to show this same photo ID at all study visits
• Arrive 30 minutes before your appointment to complete paper work.