A Study for Type 2 Diabetic Patients

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

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

Primary Measures

• Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
  • Time Frame: Baseline, 48 weeks
    Safety Issue?: No

Secondary Measures

• Change in Hemoglobin A1c (HbA1c) Over Time
  • Time Frame: Baseline, 16 Weeks, 32 Weeks, 48 Weeks
    Safety Issue?: No
• Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: No
• 7-point Self-monitored Blood Glucose Profiles
  • Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: No
• Change From Baseline in Postprandial Blood Glucose Over Time
  • Time Frame: Baseline, 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: No
• Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: No
• Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
  • Time Frame: 16 weeks, 32 weeks, 48 weeks
    Safety Issue?: No
• Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
  • Time Frame: baseline, 48 weeks
    Safety Issue?: Yes
• Safety: Number of Participants With Serious and Non-Serious Adverse Events
  • Time Frame: baseline through 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
• Hemoglobin A1c (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 (Pioglitazone)
• 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 35 kg/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 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  

Information obtained from ClinicalTrials.gov on February 09, 2012

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