Type 2 DiabetesPhase 4NCT00551538
24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
A Phase 4 study testing Lispro mix 75/25 and Glargine in people with Type 2 Diabetes, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lispro mix 75/25 and Glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2004
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes
- Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
- Have used:
- single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
- insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
- a combination of the above.
Show all 12Show fewer
- Are greater than or equal to 21 and less than 80 years of age
- As determined by the investigator, are capable and willing to:
- comply with their prescribed diet and medication regimen,
- perform self blood glucose monitoring,
- use the patient diary as required for this protocol,
- participate in two 24 hour inpatient assessments
Who cannot join
- Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
- Are currently treated with a meglitinide without sulfonylurea
- Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
- Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
- Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
Trial locations and contacts
1 site in 1 country.
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, 46202
About this study
Official title: Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
Read the detailed description
The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
- Conditions
- Type 2 Diabetes
- Being tested
- Lispro mix 75/25, Glargine
- Keywords
- Diabetes, Diabetic, Insulin, 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.
Lispro mix 75/25Drug
Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
GlargineDrug
SC injection, once-daily, given in conjunction with oral antidiabetic medications.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications. Receives: Drug: Lispro mix 75/25 |
| 2 | Active comparator | Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications. Receives: Drug: Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
Measured: At end of treatment arm or 3 months.
Secondary outcomes (8)
HbA1c
Measured: At end of treatment arm or 3 months.
2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
Measured: At end of treatment arm or 3 months.
Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL)
Measured: At end of treatment arm or 3 months.
The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
Measured: At end of treatment arm or 3 months.
The mean amplitude of glycemic excursion
Measured: At end of treatment arm or 3 months.
Concentration of plasma triglycerides and free fatty acids
Measured: At end of treatment arm or 3 months.
Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
Measured: At end of treatment arm or 3 months.
Insulin dose and body weight
Measured: At end of treatment arm or 3 months.
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 startMay 2003
- Study completionDec 2004
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 Type 2 DiabetesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00551538
- Sponsor's protocol ID
- 7505
- Other IDs
- F3Z-MC-IOOM
- Status last verified
- Oct 2010
- First submitted
- 29 Oct 2007
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Roach P, Malone JK. Comparison of insulin lispro mixture 25/75 with insulin glargine during a 24-h standardized test-meal period in patients with Type 2 diabetes. Diabet Med. 2006 Jul;23(7):743-9. doi: 10.1111/j.1464-5491.2006.01895.x.
PubMed 16842478
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
- Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine
- ClinicalTrials.gov ID
- NCT00551538
- Acronym / sponsor ID
- 7505
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Diabetic, Insulin, Glargine, Lispro
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Dec 2004 (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.
The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.
Detailed description
The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Lispro mix 75/25Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications. |
| 2 | Active comparator | Drug: GlargineGlargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have type 2 diabetes
- Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
- Have used:
- Are greater than or equal to 21 and less than 80 years of age
- As determined by the investigator, are capable and willing to:
Key exclusion criteria (5 listed)
- Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
- Are currently treated with a meglitinide without sulfonylurea
- Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
- Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
- Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1
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 mix 75/25Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications. | Drug | 1 |
| GlargineSC injection, once-daily, given in conjunction with oral antidiabetic medications. | Drug | 2 |
Primary outcome
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
Time frame: At end of treatment arm or 3 months.
8 secondary outcomes
HbA1c
Time frame: At end of treatment arm or 3 months.
2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
Time frame: At end of treatment arm or 3 months.
Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL)
Time frame: At end of treatment arm or 3 months.
The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
Time frame: At end of treatment arm or 3 months.
The mean amplitude of glycemic excursion
Time frame: At end of treatment arm or 3 months.
Concentration of plasma triglycerides and free fatty acids
Time frame: At end of treatment arm or 3 months.
Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
Time frame: At end of treatment arm or 3 months.
Insulin dose and body weight
Time frame: At end of treatment arm or 3 months.
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 publication: PubMed 16842478Roach P, Malone JK. Comparison of insulin lispro mixture 25/75 with insulin glargine during a 24-h standardized test-meal period in patients with Type 2 diabetes. Diabet Med. 2006 Jul;23(7):743-9. doi: 10.1111/j.1464-5491.2006.01895.x.
- 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 4 study testing Lispro mix 75/25 and Glargine in people with Type 2 Diabetes, run by Eli Lilly and Company at 1 site in United States.
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 12 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 1 site in United States. 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?
Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period. (time frame: At end of treatment arm or 3 months.). 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 NCT00551538, 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.