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

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ClinicalTrials.gov Identifier: NCT00099515
Recruitment Status : Completed
First Posted : December 16, 2004
Last Update Posted : December 21, 2007
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY041001 (HIIP) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard Training Versus Intensive Training for HIIP Delivery System Usage in Insulin-Naïve Patients With Type 2 Diabetes Mellitus
Study Start Date : November 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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



Primary Outcome Measures :
  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 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Assess the suitability of the HIIP delivery system for type 2 diabetes patients [ Time Frame: 4 weeks ]
  2. 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 ]
  3. Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099515


Locations
United States, Florida
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
United States, New York
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
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
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.
Sante Fe, Rosario, Argentina
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.
Norway, Portugal
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.
George, South Africa
Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
Investigators
Study Director: 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00099515     History of Changes
Other Study ID Numbers: 9523
H7U-MC-IDAP
First Posted: December 16, 2004    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases