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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT01582451
Eligibility Criteria:
Inclusion Criteria:
* Have had type 2 diabetes mellitus for at least 1 year
* Have been receiving basal insulin (neutral protamine Hagedorn \[NPH\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
* Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
* Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2)
* Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Exclusion Criteria:
* Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
* Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
* For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
* Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
* Have had any episodes of severe hypoglycemia within 6 months prior to screening
* Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
* Have cardiac disease with functional status that is New York Heart Association Class III or IV
* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter \[µmol/L\])
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
* Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
* Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter \[mmol/L\]) at screening
* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
* Lipid-lowering medication: Are using or have used any of the following:
* niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
* lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01582451
Study Brief:
Protocol Section:
NCT01582451