Summary:
ICON Development Solutions is conducting a research study for Type 2 Diabetic adults ages 18-65. This study is being done to test the safety and tolerability of an investigative drug being developed for better glycemic control in the treatment of Type 2 Diabetes. The study drug will be administered orally.
Vital signs, ECGs, glucose monitoring and physical examinations will be performed as well as blood and urine samples will be obtained during this study.
Participants will complete:
- 1 screening visit
- 17 consecutive overnight stays at the clinic
- Up to 4 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8 hour fast.
Qualified participants may be compensated up to $4,573 for time and travel.
If you are able to answer “ YES” to the following statements, you may qualify for this study.
- I have no other significant medical conditions other than Type 2 Diabetes
- I am between 18 and 65 years old
- My BMI is between 18 and 40.0 kg/m2
- I do not smoke or use any tobacco products and I have not used nicotine or nicotine-containing products for at least 3 months
- I have not participated in another investigational trial within 4 weeks prior to screening for this study
- I am a diagnosed Type 2 Diabetic on ONE of the following treatments:
- I am treating my diabetes with diet and exercise alone
- I am using a maximum of 2 oral diabetic medications
- I am have not used any injectable diabetic medication in the last 6 months
- I am willing to wash off of my oral diabetic medication beginning at least 2 weeks prior to 1st dose for this study and remain off of my treatment until 4 days after the last dose of this study
- I am not taking any beta blocker medication
- I do not have a history of Type 1 Diabetes
- I do not use illegal drugs and I do not have a history of drug abuse within the last 12 months
- If Female, I have been postmenopausal for at least 1 year or I am surgically sterile (bilateral tubal ligation, bilateral oophorectomy, hysterectomy) and I have documentation. If documentation is unavailable for a hysterectomy, an ultrasound can be used to confirm the procedure
- I do not have a history of endocrine (except Type 2 Diabetes), gastrointestinal (digestive system), cardiovascular (circulatory system), hematological (blood), hepatic (liver), immunological, renal (kidney), respiratory, reproductive or urinary abnormalities or disease
- I do not have a history of cancer, or, my non-melanomatous skin cancer or cervical cancer was successfully treated, or, my malignancy was successfully treated ≥ 10 years ago
- I do not have unstable diabetic retinopathy, neuropathy and/or severe gastroesophageal reflux or early satiety
- I have not had major surgery, donated or lost blood within 4 weeks of screening for this study
- I am able to follow a standard weight-maintaining diet throughout the study as directed
- I will avoid strenuous physical activity from screening throughout the trial until after the follow-up visit
- I am willing to avoid consumption of grapefruit, grapefruit juice and all grapefruit products beginning 2 weeks prior to 1st dose and throughout the study until after the follow-up visit
- I do not have a history of any significant multiple and/or severe allergies and I have not had an anaphylactic reaction or significant intolerability to any drug or food
- I tolerate oral medication well
- I have not had problems having blood drawn in either arm