Diabetes Mellitus, Type 2Phase 4NCT00110370
Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
A Phase 4 study testing Lispro Mixture Therapy and Glargine Basal-Bolus Therapy in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 48 sites in 2 countries.
Trial summary
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lispro Mixture Therapy and Glargine Basal-Bolus Therapy
- How many people
- 300 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Apr 2004to Apr 2006
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have type 2 diabetes.
- Must be 30-75 years of age at the time of Visit 1.
- Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- Must be on at least 30 units of glargine per day at enrollment.
- Have an A1C between 7.5% and 12.0% at Visit 1.
Who cannot join
- Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- Must not have more than one episode of severe hypoglycemia in the last 6 months.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have congestive heart failure that requires medications.
- Must not have had a kidney transplant or currently receiving dialysis
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States44 sites
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Anniston, Alabama
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Aventura, Florida
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Beaumont, Texas
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Beaver, Pennsylvania
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Birmingham, Alabama
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Bloomfield Hills, Michigan
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Butte, Montana
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Charleston, West Virginia
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Colorado Springs, Colorado
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Concord, California
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Corvallis, Oregon
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Dallas, Texas
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Federal Way, Washington
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Greenville, South Carolina
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Hollywood, Florida
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Houston, Texas
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Inglewood, California
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Irving, Texas
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Jefferson City, Missouri
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La Jolla, California
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Lexington, Kentucky
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Maitland, Florida
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Melbourne, Florida
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Memphis, Tennessee
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Metairie, Louisiana
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Mineola, New York
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New Brunswick, New Jersey
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Ogden, Utah
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Omaha, Nebraska
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Orange, California
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Phoenix, Arizona
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Portland, Oregon
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Raleigh, North Carolina
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Reno, Nevada
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Renton, Washington
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Salt Lake City, Utah
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San Antonio, Texas
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Springfield, Massachusetts
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Syracuse, New York
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Topeka, Kansas
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Tulsa, Oklahoma
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West Hills, California
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West Palm Beach, Florida
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Wichita, Kansas
Puerto Rico4 sites
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Manati
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Ponce
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San Juan
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Toa Baja
About this study
Official title: A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lispro Mixture Therapy, Glargine Basal-Bolus Therapy
- 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.
Lispro Mixture TherapyDrug
Glargine Basal-Bolus TherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
(A1C less than 7%) with once-daily insulin glargine in combination with OADs.
Secondary outcomes (3)
To test in both arms the following: frequency and incidence
of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
body weight, SAE's and study drug related AEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2005 (estimated)
- Study startApr 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110370
- Sponsor's protocol ID
- 9057
- Other IDs
- F3Z-US-IOOQ
- Status last verified
- Nov 2007
- First submitted
- 6 May 2005
- Last updated
- 27 Nov 2007
- Results posted
- No
Publications
Shi LX, Li PF, Hou JN. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens. Diabetes Ther. 2017 Aug;8(4):915-928. doi: 10.1007/s13300-017-0286-z. Epub 2017 Jun 30.
PubMed 28667381Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. doi: 10.2337/dc07-1122. Epub 2007 Oct 12.
PubMed 17934150
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine
- ClinicalTrials.gov ID
- NCT00110370
- Acronym / sponsor ID
- 9057
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 9 May 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.
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have type 2 diabetes.
- Must be 30-75 years of age at the time of Visit 1.
- Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- Must be on at least 30 units of glargine per day at enrollment.
- Have an A1C between 7.5% and 12.0% at Visit 1.
Key exclusion criteria (5 listed)
- Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- Must not have more than one episode of severe hypoglycemia in the last 6 months.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have congestive heart failure that requires medications.
- Must not have had a kidney transplant or currently receiving dialysis
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 |
|---|---|---|
| Lispro Mixture Therapy | Drug | – |
| Glargine Basal-Bolus Therapy | Drug | – |
Primary outcome
To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
(A1C less than 7%) with once-daily insulin glargine in combination with OADs.
3 secondary outcomes
To test in both arms the following: frequency and incidence
of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
body weight, SAE's and study drug related AEs.
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 Nov 2007.
- Derived from this study: PubMed 28667381Shi LX, Li PF, Hou JN. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens. Diabetes Ther. 2017 Aug;8(4):915-928. doi: 10.1007/s13300-017-0286-z. Epub 2017 Jun 30.
- Derived from this study: PubMed 17934150Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. doi: 10.2337/dc07-1122. Epub 2007 Oct 12.
- 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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lispro Mixture Therapy and Glargine Basal-Bolus Therapy in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 48 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 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior. The study lists 4 primary outcomes in all. 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 NCT00110370, which also lists 2 linked publications.
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 Nov 2007.