Official Title: “Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication”

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Study Type: Interventional

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

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro low mixture
  • Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
• Drug: Insulin glargine
  • Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
• Drug: Insulin lispro
  • Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin lispro low mixture (1, 2 or 3 daily injections)
• Active Comparator: 2
  • Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Primary Measures

• Hemoglobin A1c
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: Yes

Secondary Measures

• Percentage of patients achieving HbA1c < 6.5 % and < 7 %
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: Yes
• 7-point self-monitored blood glucose profiles
  • Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: Yes
• Mean daily total insulin dose
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: Yes
• Lipid and cholesterol profiles
  • Time Frame: 48 weeks
    Safety Issue?: Yes
• Safety
  • Time Frame: 48 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Type 2 diabetes mellitus
• Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
• HbA1c equal to or greater than 7.0% but less than 11.0%
• Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
• Able to perform self monitoring of blood glucose

Exclusion Criteria:

• Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione
• 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 35kg/m2
• History or presence of kidney disease
• Have cardiac disease (Class III or IV)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 79 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  

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/NCT00548808

Study ID Number: 11541

ClinicalTrials.gov Identifier: NCT00548808

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Lilly Clinical Trial Registry