A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Eli Lilly and Company1 site in 1 country339 target enrollmentNovember 2007

ConditionsDiabetes Mellitus, Type 2

InterventionsInsulin Lispro Protamine Suspension Insulin Glargine

DrugsInsulin Lispro Protamine Suspension Insulin Glargine

Overview

Phase: Phase 3
Intervention: Insulin Lispro Protamine Suspension
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 339
Locations: 1
Primary Endpoint: Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Must have type 2 diabetes
•Must be at least 18 years of age and less than 75 years of age
•Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
•Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
•Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria

•Must not have used insulin on a regular basis during the past 2 years
•Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
•Must not have had more than one episode of severe hypoglycemia in the past 6 months
•Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
•Must not be pregnant or intend to get pregnant during the course of the study

Arms & Interventions

ILPS

Insulin Lispro Protamine Suspension (ILPS)

Intervention: Insulin Lispro Protamine Suspension

Glargine

Insulin Glargine

Intervention: Insulin Glargine

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

Time Frame: Baseline, Endpoint (LOCF) up to 24 weeks

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

Secondary Outcomes

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)(24 weeks, Endpoint (LOCF) up to 24 weeks)
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)(Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks)
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%(Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks)
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
Glycemic Variability at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)(Baseline to Endpoint (LOCF) up to 24 weeks)
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)(Baseline to Endpoint (LOCF) up to 24 weeks)
Actual Body Weight at Baseline and Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
Change From Baseline in Body Weight at Endpoint (LOCF)(Baseline, Endpoint (LOCF) up to 24 weeks)
Total Daily Insulin Dose at Endpoint (LOCF)(Endpoint (LOCF) up to 24 weeks)