Official Title: “A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes”

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2009

Intervention(s) in this Clinical Trial

• Drug: Insulin Glargine
  • patient glucose-level dependent, injection, once daily in the evening, 24 weeks
• Drug: Insulin Lispro Protamine Suspension
  • patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Glargine plus Insulin Lispro (2-3 injections) plus metformin
• Experimental: 2
  • Insulin Lispro Protamine Suspension plus Insulin Lispro (2-3 injections) plus metformin

Primary Measures

• Insulin Lispro Protamine Suspension provides non-inferior glycemic control to insulin glargine when these basal insulins are injected once daily together with insulin lispro injected 2-3 times daily.
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: No

Secondary Measures

• Change in HbA1c
  • Time Frame: 12 weeks and 24 weeks
    Safety Issue?: No
• Percentage of patients with HbA1c less than 7.0% and less than or equal to 6.5%
  • Time Frame: 24 weeks
    Safety Issue?: No
• 7-point self-monitored blood glucose profiles
  • Time Frame: 24 weeks
    Safety Issue?: No
• Incidence and rate of all self-reported hypoglycemic episodes
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: Yes
• Incidence of treatment-emergent adverse events
  • Time Frame: Baseline to 24 weeks
    Safety Issue?: Yes
• Body weight change
  • Time Frame: From baseline to 24 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or TZD) with insulin for at least 3 months prior to Visit 1
• HbA1c greater than or equal to 7.5% and less than or equal to 11.0%
• BMI greater than or equal to 25 and less than or equal to 45 kg/m2
• Capable and willing to follow the protocol
• Give written consent

Exclusion Criteria:

• Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
• Have a history of severe hypoglycemia in the past 6 months
• Are pregnant or may become pregnant
• Women who are breastfeeding
• Have significant cardiac disease
• Have significant renal or liver disease
• Undergoing therapy for a malignancy
• Contraindications to the study medications
• Have an irregular sleep/wake cycle
• Have an serious disease or any condition considered by the investigator to be exclusionary

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666718

Study ID Number: 12047

ClinicalTrials.gov Identifier: NCT00666718

Health Authority: Greece: Ethics Committee

Lilly Clinical Trial Registry