Summary:
ICON Early Phase Services is conducting a research study for Type 2 diabetics, adults age 30-65 who are diet controlled or takin Metformin only. This study is being done to find ways to improve glucose control and improve long-term beta cell function. This study includes IV (intravenous) infusions as well as about 4 weeks of at home dosing with one of 2 FDA -approved study drugs taken daily by mouth.
Cohort 1 Stage 1 participants will complete:
- 1 screening visit
- 4 outpatient visits
- 4 weeks of at home dosing of Glimepiride
- 4 outpatient visits
Qualified participants may be compensated up to $2,850 for time and travel.
Cohort 1 Stage 2 or Cohort 2 participants will complete:
- 1 screening visit
- 2 outpatient visits
- 4 weeks of at home dosing of either Glimepiride or Sitagliptin
- 2 outpatient visits
Qualified participants may be compensated up to $1,450 for time and travel.
To determine if you fully qualify, it will be necessary to obtain blood samples after a 10- hour fast . You will need to provide medical records to participate in this study. For more information, see below.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am between 30 and 65 years old
- My BMI is between 27.0 and 40.0 kg/m2 and my weight has been stable (less than 3% change in the past 3 months)
- I have an A1c (3-month average of your glucose level) between 7.0 and 10.0
- I have not participated in a clinical biomedical research study within two months of 1st dose (depending upon the type of study)
- I have not received treatment with an investigational drug within 30 days before 1st dose
- I am a smoker that is able to participate in inpatient stay and not smoke
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, I agree to use a non-hormonal contraception for the duration of the study. I agree to use the same contraceptive methods throughout the study. Accepted methods of contraception for you and/or your partner will be explained in detail at screening.
- If Male and I have a partner capable of becoming pregnant, I agree to use an acceptable method of contraception (as described at screening) from 1st dose of this study and continuing for at least 28 days after last dose
- I am not taking any of the following medications: beta blockers, glucocorticoids, megestrol acetate, growth hormone, nicotinic acid, octreotide, antipsychotics or antidepressants (unless on a stable regimen without a >3% changes in weight for 3 months prior to enrollment), temafloxacillin, bromocriptine, colesevelam, any antihyperglycemic agents, all weight loss drugs
- I am medically stable (controlled for at least four weeks) in my management of the following conditions: high blood pressure, high cholesterol or osteoarthritis, osteoporosis
- I do not have evidence or history of clinically significant findings for blood, kidney, hormonal, lung, gastrointestinal, heart, liver, psychiatric, nerve, tumor, allergic or clinical findings at screening (NOTE: seasonal allergies are allowed)
- I do not have any condition possibly affecting absorption (e.g., gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, gallbladder removal or hysterectomy)
- I do not have a history of regular alcohol consumption exceeding 7 drinks/week for females and 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
- I have not donated blood (except at screening) within 56 days prior to 1st dose
- I agree to remain on my same diet and exercise patterns as prior to the start of the study
- I do not have a history or sensitivity to heparin or heparin-induced thrombocytopenia
- I have not had problems having blood drawn in either arm, venous access or finger pricks