Diabetes Mellitus Type 2Phase 3IOOLNCT00551356
Lispro Mix 25 vs. Glargine in Type 2 Diabetics
A Phase 3 study testing Insulin lispro mix 25 and Glargine in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 1 site in Mexico.
Trial summary
In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. 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?
- Insulin lispro mix 25 and Glargine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2002to Jul 2003
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females who have type 2 diabetes between 1 and 10 years
- Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
- Have not been on insulin treatment within 3 months before entry into the study
- Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
- Have a body mass index below 40 kg/m²
Who cannot join
- Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
- Have a known allergy to insulin
- Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
- Have known proliferative retinopathy
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
Trial locations and contacts
1 site in 1 country.
Mexico1 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mexico City
About this study
Official title: Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2
In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.
Read the detailed description
The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Insulin lispro mix 25, Glargine
- Keywords
- Diabetes, Diabetic, Insulin, Humalog, Lantus, Glargine, Lispro
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin lispro mix 25Drug
Also called Humalog Mix25
Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
GlargineDrug
Also called Lantus
Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications. Receives: Drug: Glargine |
| 1 | Active comparator | Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications. Receives: Drug: Insulin lispro mix 25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
Measured: 16 weeks or end of study.
Secondary outcomes (7)
Hemoglobin A1c measured at endpoint
Measured: 16 weeks or end of study.
Change of hemoglobin A1c from baseline to endpoint
Measured: 16 weeks or end of study.
Glycemic control as determined by self-monitored blood glucose concentrations
Measured: 16 weeks or end of study.
The incidence and rate of self-reported hypoglycemic episodes
Measured: 16 weeks or end of study.
Body mass index (BMI)
Measured: 16 weeks or end of study.
Body weight
Measured: 16 weeks or end of study.
Total Insulin Doses
Measured: 16 weeks or end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startNov 2002
- Study completionJul 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
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
- NCT00551356
- Sponsor's protocol ID
- 7354
- Other IDs
- F3Z-ME-IOOL
- Acronym
- IOOL
- Status last verified
- Oct 2007
- First submitted
- 29 Oct 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT00551356
- Acronym / sponsor ID
- IOOL / 7354
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes, Diabetic, Insulin, Humalog, Lantus, Glargine, Lispro
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jul 2003 (actual)
- First posted
- 31 Oct 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.
In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.
Detailed description
The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: GlargineInsulin glargine given SC once-daily in conjunction with oral antidiabetic medications. |
| 1 | Active comparator | Drug: Insulin lispro mix 25Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females who have type 2 diabetes between 1 and 10 years
- Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
- Have not been on insulin treatment within 3 months before entry into the study
- Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
- Have a body mass index below 40 kg/m²
Key exclusion criteria (5 listed)
- Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
- Have a known allergy to insulin
- Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
- Have known proliferative retinopathy
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
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 mix 25Also: Humalog Mix25Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications. | Drug | 1 |
| GlargineAlso: LantusInsulin glargine given SC once-daily in conjunction with oral antidiabetic medications. | Drug | 2 |
Primary outcome
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
Time frame: 16 weeks or end of study.
7 secondary outcomes
Hemoglobin A1c measured at endpoint
Time frame: 16 weeks or end of study.
Change of hemoglobin A1c from baseline to endpoint
Time frame: 16 weeks or end of study.
Glycemic control as determined by self-monitored blood glucose concentrations
Time frame: 16 weeks or end of study.
The incidence and rate of self-reported hypoglycemic episodes
Time frame: 16 weeks or end of study.
Body mass index (BMI)
Time frame: 16 weeks or end of study.
Body weight
Time frame: 16 weeks or end of study.
Total Insulin Doses
Time frame: 16 weeks or end of study.
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 31 Oct 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin lispro mix 25 and Glargine in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 1 site in Mexico.
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 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast (time frame: 16 weeks or end of study.). 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 31 Oct 2007.