Official Title: “Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections”

A study of patients with type 2 diabetes who are not controlled on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro mid mixture MM
  • Patient specific adjusted dose, TID, SC injection x 36 weeks
• Drug: Insulin glargine
  • Patient specific adjusted dose, QD, SC injection x 36 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin lispro mid mixture MM TID
• Active Comparator: 2
  • Insulin glargine daily

Primary Measures

• Hemoglobin A1c
  • Time Frame: 36 weeks
    Safety Issue?: Yes

Secondary Measures

• Hemoglobin A1c at interval visits
  • Time Frame: 12 and 24 weeks
    Safety Issue?: Yes
• Percentage of patients who achieved Hemoglobin A1c less than or equal to 6.5%, less than 7% and less than or equal to 7% at interval visits and endpoint
  • Time Frame: 12-24-36 weeks
    Safety Issue?: Yes
• 7-point self-monitored blood glucose profiles
  • Time Frame: Baseline, 12-24-36 weeks
    Safety Issue?: Yes
• Insulin dose; total, basal, and prandial
  • Time Frame: Every visit
    Safety Issue?: No
• Number of injections per day
  • Time Frame: Every visit
    Safety Issue?: No
• Incidence and rate of self-reported hypoglycemic episodes, including nocturnal (and non-nocturnal) hypoglycemia
  • Time Frame: Every visit
    Safety Issue?: Yes
• Incidence of severe hypoglycemia
  • Time Frame: Every visit
    Safety Issue?: Yes
• Weight change
  • Time Frame: Visits 1-2-4-8-13-16-18-20-22-Early Term
    Safety Issue?: No
• Treatment-emergent adverse events
  • Time Frame: Every visit
    Safety Issue?: Yes

Inclusion Criteria:

• Have type 2 diabetes
• Have been receiving oral antihyperglycemic medications without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
• Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria:

• Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
• Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
• Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
• Have a body mass index greater than 40 kg/m2.
• Have had more than one episode of severe hypoglycemia in the last24 weeks
• Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
• Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00377858

Study ID Number: 10936

ClinicalTrials.gov Identifier: NCT00377858

Health Authority: United States: Institutional Review Board

Lilly Clinical Trial Registry