A Study for Patients With Type 1 Diabetes

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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