Summary:
ICON Development Solutions is conducting a clinical research study for healthy Type 2 diabetics, adults who are age 30-65. This study is being done to test glucose tolerance for better control of Type 2 Diabetes. The study will involve meal tolerance tests and the intravenous infusion of an FDA approved drug. There is no investigational drug being tested in this study.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 phone screen
- 1 screening visit
- 4 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after a 10 hour fast. You may need to provide medical records to participate in this study. For more information, see below.
Qualified participants may be compensated up to $800 for time and travel.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy adult with Type 2 diabetes on metformin only, or I am diet controlled. If taking metformin, I have been on a stable dose of 500-2000 mg/day for a minimum of 8 weeks.
- I am between 30–65 years old
- My BMI is between 27-40 kg/m2. My weight has been stable for the past 3 months (less than 3% change).
- If I am a smoker, I agree not to smoke while at the clinic
- I have not received an investigational study drug in a clinical trial within 30 days of the 1st dose
- I have not participated in a clinical biomedical research study within the prior two months (exclusion will depend upon the study type)
- If Female and capable of becoming pregnant, I agree not to use hormonal contraception methods and I agree not to become pregnant for the duration of the study
- If Female and capable of becoming pregnant, I agree to use an acceptable contraceptive method for the duration of the study. Acceptable methods of contraception for you and your partner will be discussed during the pre-screen and screening.
- If Male, I agree to use a medically accepted method of contraception starting from the screening period and continuing for at least 28 days after the end of the study. Medically accepted methods of contraception for you and/or your partner will be defined in detail at screening.
- If Female, I am not pregnant or breastfeeding
- I do not have evidence or history of clinically significant blood, kidney, hormonal, lung, gastrointestinal, heart, liver, psychiatric, neurologic, tumor or allergic findings at screening (seasonal allergies allowed)
- I do not have a condition that would affect absorption (for example, gastrectomy, malabsorption syndromes, abdominal surgery). Appendectomy, gallbladder removal and hysterectomy are allowed.
- I am not taking beta blockers, glucocorticoids, megestrol acetate, growth hormones, nicotinic acid, octreotide, antipsychotics, antidepressants (unless on a stable regimen and no weight change greater than 3% within 3 months prior to enrollment), thiazides, temafloxacillin, bromocriptine, colesevelam, antihyperglycemic (except for metformin), any weight loss drugs
- I do not have a history of alcohol consumption exceeding 7 drinks/week for Females or 14 drinks/week for Males within 6 months of screening
- I have not donated blood within 56 days prior to 1st dose
- I do not have a history of any sensitivity to heparin or heparin-induced thrombocytopenia
- I agree to maintain the same diet and exercise pattern during study participation as I had prior to the study
- I have not had problems having blood drawn in either arm.