Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00437112
First received: February 16, 2007
Last updated: July 15, 2008
Last verified: July 2008
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Purpose
A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Human Insulin Inhalation Powder Drug: Insulin Glargine |
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 Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive 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:
- Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean change in HbA1c from baseline to various timepoints [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Insulin dose requirements [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Patient-reported outcomes of W-BQ12 [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
- Hypoglycemia rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Changes in body weight [ Time Frame: every visit ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Safety as assessed by total pulmonary function testing and fasting lipid profile [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
- Assess inhaler reliability. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Patient Reported outcomes of DSC-R [ Time Frame: screening,baseline, week 12,24, and 48 ] [ Designated as safety issue: No ]
- Patient reported outcomes of DTSQS [ Time Frame: screening,baseline, week 12, 24 and 48 ] [ Designated as safety issue: No ]
- Patient reported outcome of IDSQ [ Time Frame: week 12, 24, and 48 ] [ Designated as safety issue: No ]
- Patient reported outcome of preference questionnaire [ Time Frame: week 48 ] [ Designated as safety issue: No ]
- Patient reported outcome of Expectations About Insulin Therapy Questionnaire [ Time Frame: screening,baseline ] [ Designated as safety issue: No ]
- Patient reported outcome of Experience with Insulin Therapy Questionnaire [ Time Frame: week 12, 24 and 48 ] [ Designated as safety issue: No ]
| Enrollment: | 142 |
| Study Start Date: | February 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period |
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 weeks
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 24 weeks
|
|
Experimental: 2
4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period |
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 weeks
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 Diabetes Mellitus
- Insulin naive
- One or more oral antihyperglycemic medications
- HbA1c greater than or equal to 8.0% and less than or equal to 10.5%
- Non-smoker
Exclusion Criteria:
- Taking a TZD dose greater than what is indicated
- Have not taken insulin within 6 months of entry into study
- Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry
- Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry
- Have had pneumonia in the 3 months prior to study entry
- Systemic glucocorticoid therapy
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis
- History of renal transplantation
- Have an active or untreated malignancy
- Have a current diagnosis or past history of clinically relevant pulmonary disease
- Taking or have taken exenatide during the 6 weeks prior to study entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437112
Locations
| United States, California | |
| 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. | |
| Greenbrae, California, United States, 94904 | |
| United States, Kansas | |
| 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. | |
| Topeka, Kansas, United States, 66606 | |
| United States, New Jersey | |
| 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. | |
| Toms River, New Jersey, United States, 08753 | |
| United States, New Mexico | |
| 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. | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, Texas | |
| 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 Braunfels, Texas, United States, 78130 | |
| 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. | |
| San Antonio, Texas, United States, 78229 | |
| Brazil | |
| 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. | |
| Porto Alegre, Brazil, 90035-003 | |
| 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. | |
| Sao Paulo, Brazil, 04025-011 | |
| India | |
| 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. | |
| Cochin, India, 682026 | |
| 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. | |
| Indore, India, 452 003 | |
| 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. | |
| Pune, India, 411005 | |
| 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. | |
| Vellore, India, 632 004 | |
| Puerto Rico | |
| 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. | |
| Manatí, Puerto Rico, 00674 | |
| 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. | |
| San Juan, Puerto Rico, 00907 | |
| Spain | |
| 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. | |
| Barakaldo, Spain, 48903 | |
| 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. | |
| Dos Hermanas, Spain, 41014 | |
| 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. | |
| Madrid, Spain, 28006 | |
| 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. | |
| Requena, Spain, 46340 | |
| 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. | |
| Sabadell, Spain, 08208 | |
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 from 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: | NCT00437112 History of Changes |
| Other Study ID Numbers: | 9631, H7U-MC-IDAZ |
| Study First Received: | February 16, 2007 |
| Last Updated: | July 15, 2008 |
| 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 Glargine |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013