NCT00099515

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2004

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

December 15, 2004

Last Update Submit

December 18, 2007

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

A

EXPERIMENTAL
Drug: LY041001 (HIIP)

B

EXPERIMENTAL
Drug: LY041001 (HIIP)

Interventions

LY041001 (HIIP)DRUG

Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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.

Clearwater, Florida, United States

Location

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.

Buffalo, New York, United States

Location

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

Location

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.

Sante Fe, Rosario, Argentina

Location

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.

Norway, Portugal

Location

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

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 15, 2004

First Posted

December 16, 2004

Study Start

November 1, 2004

Study Completion

September 1, 2005

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

AR(1)PT(1)US(3)ZA(1)