A Study for Patients With Type 1 Diabetes

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine

Key facts

Study ID

NCT01049412

Run by

Eli Lilly and Company

People needed

138

Starts

2010-01-01

Expected to finish

2011-01-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes mellitus (T1DM) for at least 1 year and using insulin glargine for at least 6 months with a maximum daily dose of 1 unit per kilogram (U/kg).
• Hemoglobin A1c (HbA1c) of no greater than 10.5% before randomization
• Body mass index (BMI) 19 to 45 kilogram per square meter (kg/m²)
• Capable and willing to prepare and inject insulin with a syringe, monitor own blood glucose, complete the study diary, be receptive to diabetes education, comply with study requirements, and receive telephone calls during treatment
• Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up

You may not qualify if…

• Twice daily use of insulin glargine within 30 days prior to the study
• Use of any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to the study
• Use of an insulin pump
• More than 1 episode of severe hypoglycemia within 3 months prior to the study, or currently diagnosed as having hypoglycemia unawareness
• 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
• Known hypersensitivity or allergy to any of the study insulins or their excipients
• Blood transfusion or severe blood loss within 3 months prior to the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
• Irregular sleep/wake cycle
• Pregnant or intend to become pregnant during the study
• Women who are breastfeeding
• Use of prescription or over-the-counter medications to promote weight loss within 3 months prior to the study
• Current participation in a weight loss program or plans to do so during the study
• Use of chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
• Cardiac disease with a marked impact on physical functioning
• Clinically significant electrocardiogram (ECG) abnormalities at screening
• Fasting triglycerides greater than 500 milligram per deciliter (mg/dL)
• Liver disease
• History of renal transplantation, current renal dialysis, or creatinine greater than 2.0 mg/dL (177 micromole per liter [μmol/L])
• Malignancy other than basal cell or squamous cell skin cancer, currently or within the last 5 years
• Treatment with any antibody-based therapy within 6 months prior to the study

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Chula Vista, California, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Atlanta, Georgia, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Idaho Falls, Idaho, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Topeka, Kansas, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Metairie, Louisiana, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Baltimore, Maryland, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Minneapolis, Minnesota, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Austin, Texas, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Dallas, Texas, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Renton, Washington, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Holon, Israel
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Petah Tikva, Israel
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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