Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP) (IDAP)
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 May 23, 2013