Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT01614769
Eligibility Criteria:
Inclusion Criteria:
* Has clinically confirmed diagnosis of type 2 diabetes mellitus (T2DM) controlled by diet and exercise alone, or treated by metformin only with same dose for \>= 12 weeks prior to screening visit.
* Females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug.
* Females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation.
* Is in good health, other than T2DM.
* Has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. If discontinued use for previous 3 months, may be enrolled at investigator's discretion.
* Will follow American Heart Association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit.
* At screening visit has a Body Mass Index (BMI) =\< 40 kg/m\^2.
* At screening visit has a Hemoglobin A1c (HbA1c) of \>= 7% and \< 10% (+/- 0.1%).
* On the morning of randomization at predose has fasting plasma glucose (FPG) \>= 126 mg/dL, and =\< 250 mg/dL.
Exclusion Criteria:
* Has a history of stroke, chronic seizures, or major neurological disorder.
* Has a history of any illness that might confound the results of the study or pose additional risk to the participant.
* Has a history of type 1 diabetes mellitus, ketoacidosis, C-peptide =\< 0.8 ng/mL, secondary forms of diabetes or diabetic complications.
* Has a history of neoplastic disease.
* Is a nursing mother.
* Has been treated =\< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs, or insulin.
* Has received treatment within =\< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (PPARγ) agonist.
* Is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study.
* Consumes excessive amounts of alcohol or caffeinated beverages.
* Is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months.
* Has had major surgery, lost 500 mL of blood, or participated in another investigational study within 4 weeks prior to screening visit.
* Is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit.
* Has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01614769
Study Brief:
Protocol Section:
NCT01614769