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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01774968
Eligibility Criteria:
Major Inclusion Criteria:
* Have type 2 diabetes mellitus (World Health Organization \[WHO\] Classification of Diabetes)
* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\^2)
* Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
* Current U-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
* Have a history of stable body weight for at least 3 months prior to study entry
* Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months
Major Exclusion Criteria:
* Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
* Have chronic kidney disease stage 4 and higher or history of renal transplantation
* Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry
* Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
* Have received U-500R in the 3 months prior to study entry
* Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
* Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
* Have an irregular sleep/wake cycle
* Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry
* Have used any weight loss drugs in the 3 months prior to study entry
* Have a history of bariatric surgery
* Have a history of malignancy other than basal cell or squamous cell skin cancer
* Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
* Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01774968
Study Brief:
Protocol Section:
NCT01774968