A Study for Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490854
First received: June 21, 2007
Last updated: July 3, 2008
Last verified: July 2008
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Purpose
The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Human Insulin Inhalation Powder Drug: Neutral protamine hagedorn insulin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 8-point SMBG profiles. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
- Mean change in HbA1c from baseline to the end. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
- Mean dosage of both preprandial and basal insulin. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
- Inhaler reliability. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
- Patient-reported outcomes questionnaires. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
| Enrollment: | 129 |
| Study Start Date: | July 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Human Insulin Inhalation Powder
patient specific, inhaled, at meals, 76 weeks
Other Name: LY 041001
Drug: Neutral protamine hagedorn insulin
patient specific dose, injected, daily, 76 weeks
|
| Experimental: 2 |
Drug: Human Insulin Inhalation Powder
patient specific, inhaled, at meals, 76 weeks
Other Name: LY 041001
Drug: Neutral protamine hagedorn insulin
patient specific dose, injected, daily, 76 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus for at least 6 months
- One or more oral antihyperglycemic medications for at least 12 weeks
- HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
- Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
- Satisfactory lung function results to meet the requirement of the study
Exclusion Criteria:
- Previously received any form of inhaled insulin
- Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
- History or presence of liver disease
- History or presence of kidney disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490854
Locations
| Japan | |
| 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. | |
| Aichi, Japan, 451-8511 | |
| 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. | |
| Chiba, Japan, 2892511 | |
| 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. | |
| Fukuoka, Japan, 830-8543 | |
| 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. | |
| Fukushima, Japan, 963-8851 | |
| 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. | |
| Gunma, Japan, 370-2393 | |
| 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. | |
| Hokkaido, Japan, 060-8648 | |
| 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. | |
| Hyogo, Japan, 663-8501 | |
| 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. | |
| Kanagawa, Japan, 235-0045 | |
| 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. | |
| Nara, Japan, 632-8552 | |
| 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. | |
| Osaka, Japan, 569-1096 | |
| 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. | |
| Shiga, Japan, 520-2192 | |
| 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. | |
| Tokyo, Japan, 150-8935 | |
| 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. | |
| Toyama, Japan, 930-8550 | |
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 9AM - 5PM 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: | NCT00490854 History of Changes |
| Other Study ID Numbers: | 10513, H7U-JE-IDBF |
| Study First Received: | June 21, 2007 |
| Last Updated: | July 3, 2008 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin, NPH Protamines |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Heparin Antagonists Molecular Mechanisms of Pharmacological Action Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013