Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company379 enrolled

Overview

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

379

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus for at least 6 months * Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening. * Patients who have been treated with the following regimen: One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]), AND have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months, AND are candidates for insulin therapy, in the opinion of the investigator. Exclusion Criteria: * Pregnancy * Smoker * History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry * Diagnosed with pneumonia in the 3 months prior to screening * Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry * History of renal transplantation * History of lung transplantation * Active or untreated malignancy * Treated with Incretin mimetics

Locations (42)

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.

Santa Ana, California, United States

Washington D.C., District of Columbia, United States

Hollywood, Florida, United States

New Port Richey, Florida, United States

Outcomes

Primary Outcomes

Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach.

Time frame: 6 months

Secondary Outcomes

Mean change in HbA1c from baseline to various endpoints.

Time frame: 6 months

Patient safety

Time frame: throughout the study

Patient reported outcome from W-BQ12

Time frame: screening,baseline,month 6

Treatment satisfaction

Time frame: 6 months

Insulin dose

Time frame: throughout the study

Patient reported outcome from DSC-R

Time frame: screening,baseline, month 6

Patient reported outcome from DTSQS

Time frame: screening,baseline, month 6

Patient reported outcome from IDSQ

Time frame: Month 1, 2 and 6

Patient reported outcome from "Expectations About Insulin Therapy Questionnaire"

Time frame: baseline, screening, month 6

Data from ClinicalTrials.gov

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South Miami, Florida, United States

Honolulu, Hawaii, United States

Idaho Falls, Idaho, United States

New Orleans, Louisiana, United States

Biddeford, Maine, United States

Minneapolis, Minnesota, United States

...and 32 more locations