A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

Verified by: Eli Lilly and Company, May 2011
First Received: April 23, 2008 | Last Updated: May 11, 2011 | Phase: Phase 3 | Start Date: April 2008
Overall Status: Completed | Estimated Enrollment: 374
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This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) 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)...

Brief Summary

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 (ILPS) 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: February 2010

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 (ILPS)
    • patient glucose-level dependent, injection, once daily in the evening, 24 weeks
  • Drug: Insulin Lispro
    • subcutaneous injections prior to meals, 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24
    • Time Frame: Baseline, Week 24
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in HbA1c at Week 12 and Week 24
    • Time Frame: Baseline, Week 12, Week 24
      Safety Issue?: No
  • Percentage of Participants With HbA1c Less Than 7.0% and Less Than or Equal to 6.5% at Endpoint
    • Time Frame: Week 24
      Safety Issue?: No
  • 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Glycemic Variability at Endpoint
    • Time Frame: Week 24
      Safety Issue?: No
  • Rate Of All Self-reported Hypoglycemic Episodes
    • Time Frame: Baseline through Week 24
      Safety Issue?: Yes
  • Percentage of Participants With Self-Reported Hypoglycemic Episodes
    • Time Frame: Baseline through Week 24
      Safety Issue?: Yes
  • Number of Participants With Adverse Events (AE)
    • Time Frame: Baseline through Week 24
      Safety Issue?: Yes
  • Change in Body Weight From Baseline to Week 24
    • Time Frame: Baseline, Week 24
      Safety Issue?: Yes
  • Total Daily Insulin Dose at Endpoint
    • Time Frame: Week 24
      Safety Issue?: No
  • Number of Injections of Insulin at Week 24
    • Time Frame: Week 24
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Diabetes Mellitus, Type 2
  • Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
  • Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
  • Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
  • 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 a 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

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

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  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00666718