Diabetes Mellitus, Type 2Phase 2/3NCT00490854
A Study for Patients With Type 2 Diabetes Mellitus
A Phase 2/3 study testing Human Insulin Inhalation Powder and Neutral protamine hagedorn insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 13 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Human Insulin Inhalation Powder and Neutral protamine hagedorn insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 13 sitesJapan
- Study dates
- Jul 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 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 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.
Aichi, 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, 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, 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, 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, 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, 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.
Hyōgo, 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, 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, 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, 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, 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, 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, 930-8550
About this study
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
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Human Insulin Inhalation Powder, Neutral protamine hagedorn insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Insulin Inhalation PowderDrug
Also called LY 041001
patient specific, inhaled, at meals, 76 weeks
Neutral protamine hagedorn insulinDrug
patient specific dose, injected, daily, 76 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Human Insulin Inhalation Powder; Drug: Neutral protamine hagedorn insulin |
| 2 | Experimental | Not described Receives: Drug: Human Insulin Inhalation Powder; Drug: Neutral protamine hagedorn insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
Measured: 24, 48 and 76 weeks after Randomization
Secondary outcomes (5)
8-point SMBG profiles.
Measured: 24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.
Measured: 24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.
Measured: 24, 48 and 76 weeks after Randomization
Inhaler reliability.
Measured: 24, 48 and 76 weeks after Randomization
Patient-reported outcomes questionnaires.
Measured: 24, 48 and 76 weeks after Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startJul 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.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 129 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 (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490854
- Sponsor's protocol ID
- 10513
- Other IDs
- H7U-JE-IDBF
- Status last verified
- Jul 2008
- First submitted
- 21 Jun 2007
- Last updated
- 10 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. 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 Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents
- ClinicalTrials.gov ID
- NCT00490854
- Acronym / sponsor ID
- 10513
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Alkermes, Inc.
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Jun 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 oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication 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: Human Insulin Inhalation Powder, Drug: Neutral protamine hagedorn insulin |
| 2 | Experimental | Drug: Human Insulin Inhalation Powder, Drug: Neutral protamine hagedorn 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 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Human Insulin Inhalation PowderAlso: LY 041001patient specific, inhaled, at meals, 76 weeks | Drug | 1, 2 |
| Neutral protamine hagedorn insulinpatient specific dose, injected, daily, 76 weeks | Drug | 1, 2 |
Primary outcome
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
5 secondary outcomes
8-point SMBG profiles.
Time frame: 24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.
Time frame: 24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.
Time frame: 24, 48 and 76 weeks after Randomization
Inhaler reliability.
Time frame: 24, 48 and 76 weeks after Randomization
Patient-reported outcomes questionnaires.
Time frame: 24, 48 and 76 weeks after Randomization
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 10 Jul 2008.
- 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 (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Human Insulin Inhalation Powder and Neutral protamine hagedorn insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 13 sites in Japan.
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 4 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 10 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2008.