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

December 18, 2007 updated by: Eli Lilly and Company

Standard Training Versus Intensive Training for HIIP Delivery System Usage in Insulin-Naïve Patients With Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Rosario
      • Sante Fe, Rosario, Argentina
        • 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.
  • Portugal
      • Norway, Portugal
        • 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.
  • South Africa
      • George, South Africa
        • 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.
  • United States
    • Florida
      • Clearwater, Florida, United States
        • 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.
    • New York
      • Buffalo, New York, United States
        • 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.
      • New Hyde Park, New York, United States
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: LY041001 (HIIP)
Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
Drug: LY041001 (HIIP)
Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
Experimental: B
Drug: LY041001 (HIIP)
Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
Drug: LY041001 (HIIP)
Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the suitability of the HIIP delivery system for type 2 diabetes patients
Time Frame: 4 weeks
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
Time Frame: 4 weeks
4 weeks
Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

December 15, 2004

First Submitted That Met QC Criteria

December 15, 2004

First Posted (Estimate)

December 16, 2004

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9523
  • H7U-MC-IDAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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