Diabetes Mellitus, Type 1Phase 2/3NCT00447213
A Study for Patients With Type 1 Diabetes Mellitus
A Phase 2/3 study testing Insulin glargine, Human Insulin Inhalation Powder and Injectable Insulin in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 5 sites in 2 countries.
Trial summary
The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin glargine, Human Insulin Inhalation Powder and Injectable Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2007to May 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus for at least 24 months
- Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
- HbA1c equal or less than 11 %
- Nonsmokers, had 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
Who cannot join
- Previously received any form of inhaled insulin
- Require a daily total insulin dosage greater than 100 U
- Have a current 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Taiwan3 sites
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.
Changhua, 500
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.
Taipei, 104
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.
Taoyuan, 333
Japan2 sites
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, 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.
Tokyo, 160-0023
About this study
Official title: A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin glargine, Human Insulin Inhalation Powder, Injectable Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Patient specific, injected, daily, 24 weeks
Human Insulin Inhalation PowderDrug
Also called LY041001
patient specific dose, inhaled, before meals,12 weeks
Injectable InsulinDrug
Patient specific dose,injected, before meals, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Insulin glargine; Drug: Human Insulin Inhalation Powder; Drug: Injectable Insulin |
| 2 | Experimental | Not described Receives: Drug: Insulin glargine; Drug: Human Insulin Inhalation Powder; Drug: Injectable Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline
Measured: 12 and 24 weeks
Secondary outcomes (7)
Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
Measured: 12 and 24 weeks
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
Measured: at each visit
8-point self monitoring blood glucose profiles
Measured: 12 and 24 weeks
Two hour glucose excursions for the morning, midday, and evening meals
Measured: 12 and 24 weeks
Inhaler reliability
Measured: throughout the study
Patient-reported treatment satisfaction and insulin delivery satisfaction
Measured: 12 and 24 weeks
Preference for the study therapies
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alkermes, Inc.
- Investigators
- Call 1-877-CTLILLY (1-277-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447213
- Sponsor's protocol ID
- 10299
- Other IDs
- H7U-JE-IDBB
- Status last verified
- Oct 2010
- First submitted
- 12 Mar 2007
- Last updated
- 13 Oct 2010
- Results posted
- No
Publications
Hitoshi Ishii, Satoru Tsujii, Masami Tanaka, Miyuki Furuya, Tadao Iburi, Rei Ueda, Sakura Okuyama, Risa P. Hayes, Masato Okamura, Kazuya Iwamoto, Eisei Oda. Development of IDSQ-J and assessment of reproducibility adequacy. Tonyobyo. 2009;52(3):209-221.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00447213
- Acronym / sponsor ID
- 10299
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Alkermes, Inc.
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin glargine, Drug: Human Insulin Inhalation Powder, Drug: Injectable Insulin |
| 2 | Experimental | Drug: Insulin glargine, Drug: Human Insulin Inhalation Powder, Drug: Injectable Insulin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes mellitus for at least 24 months
- Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
- HbA1c equal or less than 11 %
- Nonsmokers, had 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
Key exclusion criteria (5 listed)
- Previously received any form of inhaled insulin
- Require a daily total insulin dosage greater than 100 U
- Have a current 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glarginePatient specific, injected, daily, 24 weeks | Drug | 1, 2 |
| Human Insulin Inhalation PowderAlso: LY041001patient specific dose, inhaled, before meals,12 weeks | Drug | 1, 2 |
| Injectable InsulinPatient specific dose,injected, before meals, 12 weeks | Drug | 1, 2 |
Primary outcome
Change in HbA1c from baseline
Time frame: 12 and 24 weeks
7 secondary outcomes
Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
Time frame: 12 and 24 weeks
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
Time frame: at each visit
8-point self monitoring blood glucose profiles
Time frame: 12 and 24 weeks
Two hour glucose excursions for the morning, midday, and evening meals
Time frame: 12 and 24 weeks
Inhaler reliability
Time frame: throughout the study
Patient-reported treatment satisfaction and insulin delivery satisfaction
Time frame: 12 and 24 weeks
Preference for the study therapies
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Results publicationHitoshi Ishii, Satoru Tsujii, Masami Tanaka, Miyuki Furuya, Tadao Iburi, Rei Ueda, Sakura Okuyama, Risa P. Hayes, Masato Okamura, Kazuya Iwamoto, Eisei Oda. Development of IDSQ-J and assessment of reproducibility adequacy. Tonyobyo. 2009;52(3):209-221.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-277-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin glargine, Human Insulin Inhalation Powder and Injectable Insulin in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline (time frame: 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.