Type 2 Diabetes MellitusPhase 3NCT00231725
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin
A Phase 3 study testing insulin lispro injection [rDNA origin] Low Mix in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 4 sites in 3 countries.
Trial summary
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- insulin lispro injection [rDNA origin] Low Mix
- Type of treatment
- Injection or infusion
- How many people
- 370 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Sep 2005to Apr 2006
- Phase
- Phase 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes
- Already on Lilly insulin or beginning insulin therapy
- 25 to 75 years old inclusive
Who cannot join
- Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
- More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 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.
Pamplona
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
United States1 site
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.
Memphis, Tennessee
United Kingdom1 site
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.
Middlesbrough
About this study
Official title: Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin lispro injection [rDNA origin] Low Mix
- 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.
insulin lispro injection [rDNA origin] Low MixDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
Secondary outcomes (2)
To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
To assess overall patient perception of the device's performance through a patient questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 370 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231725
- Sponsor's protocol ID
- 9673
- Other IDs
- H9D-MC-ITAB
- Status last verified
- Jun 2007
- First submitted
- 30 Sep 2005
- Last updated
- 27 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy
- ClinicalTrials.gov ID
- NCT00231725
- Acronym / sponsor ID
- 9673
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 4 Oct 2005 (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.
Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes
- Already on Lilly insulin or beginning insulin therapy
- 25 to 75 years old inclusive
Key exclusion criteria (2 listed)
- Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
- More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
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 lispro injection [rDNA origin] Low Mix | Drug | – |
Primary outcome
To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.
2 secondary outcomes
To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia
To assess overall patient perception of the device's performance through a patient questionnaire.
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 27 Jun 2007.
- 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin lispro injection [rDNA origin] Low Mix in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 4 sites in 3 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 3 inclusion and 2 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 27 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, United States, United Kingdom. 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 phase mean?
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?
To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.. 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 27 Jun 2007.