A Study for Patients With Type 2 Diabetes

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

Summary

Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with 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 2 diabetes mellitus (T2DM) for at least 1 year

• At least 18 years of age

• Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.

• Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization

• Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)

• Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits

• Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit

Exclusion Criteria:

• Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted

• Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study

• Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study

• Current participation in a weight loss program, or plans to do so during the study

• Treatment with any antibody-based therapy within 6 months prior to the study

• Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study

• More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness

• 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study

• Liver disease

• History of renal transplantation, current renal dialysis, or creatinine >2.0 milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)

• Cardiac disease with a marked impact on physical functioning

• Clinically significant electrocardiogram (ECG) abnormalities at screening

• Malignancy other than basal cell or squamous cell skin cancer

• Fasting triglycerides >500 mg/dL

• Known diabetic autonomic neuropathy

• Known hypersensitivity or allergy to study insulin or its excipients

• Blood transfusion or severe blood loss within 3 months prior to entry into 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

• Women who are breastfeeding