A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents

Eli Lilly and Company1 site in 1 country129 target enrollmentJuly 2007

ConditionsDiabetes Mellitus, Type 2

InterventionsNeutral protamine hagedorn insulin Human Insulin Inhalation Powder

DrugsHuman Insulin Inhalation Powder Neutral protamine hagedorn insulin

Overview

Phase: Phase 2
Intervention: Neutral protamine hagedorn insulin
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 129
Locations: 1
Primary Endpoint: Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

May 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Type 2 diabetes mellitus for at least 6 months
•One or more oral antihyperglycemic medications for at least 12 weeks
•HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
•Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
•Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria

•Previously received any form of inhaled insulin
•Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
•History or presence of liver disease
•History or presence of kidney disease

Arms & Interventions

1

Intervention: Neutral protamine hagedorn insulin

1

Intervention: Human Insulin Inhalation Powder

2

Intervention: Human Insulin Inhalation Powder

2

Intervention: Neutral protamine hagedorn insulin

Outcomes

Primary Outcomes

Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase

Time Frame: 24, 48 and 76 weeks after Randomization

Secondary Outcomes

8-point SMBG profiles.(24, 48 and 76 weeks after Randomization)
Mean change in HbA1c from baseline to the end.(24, 48 and 76 weeks after Randomization)
Mean dosage of both preprandial and basal insulin.(24, 48 and 76 weeks after Randomization)
Inhaler reliability.(24, 48 and 76 weeks after Randomization)
Patient-reported outcomes questionnaires.(24, 48 and 76 weeks after Randomization)