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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00099515
First received: December 15, 2004
Last updated: December 18, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY041001 (HIIP)
Drug: LY041001 (HIIP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the suitability of the HIIP delivery system for type 2 diabetes patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: November 2004
Study Completion Date: September 2005
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00099515     History of Changes
Other Study ID Numbers: 9523, H7U-MC-IDAP
Study First Received: December 15, 2004
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014