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COMPLETEDPHASE3

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus

NCT00494013•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have type 2 diabetes mellitus for at least 1 year.
•2. Are at least 18 years old.
•3. Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
•4. Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
•5. Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

•1. Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
•2. Have taken any glucose-lowering medications not included in Inclusion Criterion \[3\] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
•3. Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
•4. Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter \[micromol/L\]).
•5. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase \[ALT\], or aspartate transaminase \[AST\] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.

Locations (56)

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.

Hueytown, Alabama, United States

Litchfield Park, Arizona, United States

Phoenix, Arizona, United States

Buena Park, California, United States

Fountain Valley, California, United States

Los Angeles, California, United States

Jacksonville, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Evansville, Indiana, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

September 1, 2008

Completion Date

September 1, 2008

Last Updated

November 11, 2009

Enrollment

442

ACTUAL participants

Conditions

Diabetes Mellitus Type 2

Interventions

Insulin Lispro Protamine Suspension

DRUG

Detemir

DRUG

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

NCT06525259

Diabetes Mellitus Type 2, Childhood-Onset

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RECRUITINGNA

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT07011147

Type 1 Diabetes (T1D)Type 2 Diabetes+9 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 11, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

Inclusion Criteria

Exclusion Criteria

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