Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY041001 (HIIP)

• Registration Number: NCT00099515
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2004-12-15
• Study First Submitted QC: 2004-12-15
• Study First Posted: 2004-12-16
• Study Completion: 2005-09
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Type 2 diabetes for at least 12 months
• Age 18 or older.
• Taking at least 1 oral antihyperglycemic medication.
• Have an HbA1C between 7.5 and 12.
• Be a nonsmoker

Exclusion Criteria

• Body Mass Index (BMI) greater than 40.
• Have frequent episodes of severe hypoglycemia.
• Have advanced autonomic neuropathy.
• Have history of asthma.
• Have chronic obstructive pulmonary disease (COPD).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	LY041001 (HIIP)	-
B	LY041001 (HIIP)	-

Primary Outcome Measures

Name	Time	Method
Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP	4 weeks

Secondary Outcome Measures

Name	Time	Method
Assess the suitability of the HIIP delivery system for type 2 diabetes patients	4 weeks
Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training	4 weeks
Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training	4 weeks

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.; 🇿🇦 George, South Africa