A Study for Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin lispro low mixture; Drug: Insulin glargine; Drug: Insulin lispro

• Registration Number: NCT00548808
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Study Start: 2007-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-08
• Results First Submitted: 2010-08-20
• Results First Submitted QC: 2010-08-20
• Last Update Submitted: 2010-08-20
• Results First Posted: 2010-09-15
• Last Update Posted: 2010-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin lispro low mixture	Insulin lispro low mixture	Insulin lispro low mixture (1, 2 or 3 daily injections)
Insulin glargine	Insulin glargine	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
Insulin glargine	Insulin lispro	Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)	Baseline, 48 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c (HbA1c) Over Time	Baseline, 16 Weeks, 32 Weeks, 48 Weeks
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time	16 weeks, 32 weeks, 48 weeks
7-point Self-monitored Blood Glucose Profiles	Baseline, 16 weeks, 32 weeks, 48 weeks
Change From Baseline in Postprandial Blood Glucose Over Time	Baseline, 16 weeks, 32 weeks, 48 weeks	The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks	16 weeks, 32 weeks, 48 weeks
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks	16 weeks, 32 weeks, 48 weeks
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles	baseline, 48 weeks
Safety: Number of Participants With Serious and Non-Serious Adverse Events	baseline through 48 weeks	Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇲🇽 Monterrey, Mexico