Expired Study
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Buffalo, New York


Purpose:

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


Criteria:

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 is Available At:


Original ID:

9523


NCT ID:

NCT00099515


Secondary ID:

H7U-MC-IDAP


Study Acronym:

IDAP


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

97


Enrollment Type:

Actual


Overall Contact Information

Official Name:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Study Dates

Start Date:November 2004
Completion Date:September 2005
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 18, 2007
First Received Date:December 15, 2004

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:LY041001 (HIIP)
Description:Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU
Arm Name:A
Intervention Type:Drug
Name:LY041001 (HIIP)
Description:Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU
Arm Name:B

Study Arms

Study Arm Type:Experimental
Arm Name:A
Study Arm Type:Experimental
Arm Name:B

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Alkermes

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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