Diabetes Mellitus, Type 2Phase 3NCT00560417
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
A Phase 3 study testing Insulin Lispro Protamine Suspension and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 52 sites in 2 countries.
Trial summary
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Lispro Protamine Suspension and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 52 sitesin 2 countries
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Who cannot join
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
United States49 sites
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Austin, Texas, 78731
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Avon, Indiana, 46123
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Baton Rouge, Louisiana, 70808
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Biddeford, Maine, 04005
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Bloomington, Indiana, 47403
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Chesterfield, Missouri, 63017
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Concord, California, 94520
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Dallas, Texas, 75231
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Des Moines, Iowa, 50314
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Escondido, California, 92026
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Fresno, California, 93720
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Greer, South Carolina, 29651
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Honolulu, Hawaii, 96813
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Idaho Falls, Idaho, 83404
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Inverness, Florida, 34452
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Jacksonville, Florida, 32204
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Jefferson City, Missouri, 65109
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Kingsport, Tennessee, 37660
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Lafayette, Louisiana, 70503
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Lake Worth, Florida, 33461
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Las Vegas, Nevada, 89148
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Lexington, Kentucky, 40503
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London, Ohio, 43140
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Mason, Ohio, 45040
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Memphis, Tennessee, 38119
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Metairie, Louisiana, 70006
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Miami, Florida, 33183
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Modesto, California, 95355
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Morehead City, North Carolina, 28557
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Myrtle Beach, South Carolina, 29572
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Nashua, New Hampshire, 03063
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Omaha, Nebraska, 68131
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Orange, California, 92869
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Orlando, Florida, 32804
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Palm Harbor, Florida, 34684
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Pembroke Pines, Florida, 33029
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Phoenix, Arizona, 85028
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Plantation, Florida, 33324
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Rochester, New York, 14607
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San Antonio, Texas, 78229
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South Bend, Indiana, 46617
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South Burlington, Vermont, 05403
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Spokane, Washington, 99202
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St Louis, Missouri, 63104
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Syracuse, New York, 13210
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Toledo, Ohio, 43606
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Vancouver, Washington, 98664
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Virginia Beach, Virginia, 23462
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West Palm Beach, Florida, 33401
Puerto Rico3 sites
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Ponce, 00731
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Toa Baja, 00949
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Yabucoa, 00767
About this study
Official title: A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Lispro Protamine Suspension, Insulin Glargine
- 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 Protamine SuspensionDrug
Also called LY275585[P]
Administered subcutaneously once a day at bedtime
Insulin GlargineDrug
Also called Lantus
Administered subcutaneously once a day at bedtime
| Study group | Role | What they receive |
|---|---|---|
| ILPS | Active comparator | Insulin Lispro Protamine Suspension (ILPS) Receives: Drug: Insulin Lispro Protamine Suspension |
| Glargine | Active comparator | Insulin Glargine Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
Measured: Baseline, Endpoint (LOCF) up to 24 weeks
Secondary outcomes (10)
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Measured: 24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Measured: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Measured: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.
Measured: Baseline, Endpoint (LOCF) up to 24 weeks
Glycemic Variability at Baseline and Endpoint (LOCF)
Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.
Measured: Baseline, Endpoint (LOCF) up to 24 weeks
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
Measured: Baseline to Endpoint (LOCF) up to 24 weeks
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.
Measured: Baseline to Endpoint (LOCF) up to 24 weeks
Actual Body Weight at Baseline and Endpoint (LOCF)
Measured: Baseline, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Body Weight at Endpoint (LOCF)
Measured: Baseline, Endpoint (LOCF) up to 24 weeks
Total Daily Insulin Dose at Endpoint (LOCF)
Measured: Endpoint (LOCF) up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 339 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
- NCT00560417
- Sponsor's protocol ID
- 11647
- Other IDs
- F3Z-US-IOPB
- Status last verified
- Jan 2011
- First submitted
- 15 Nov 2007
- Last updated
- 13 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
- ClinicalTrials.gov ID
- NCT00560417
- Acronym / sponsor ID
- 11647
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 14 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILPS | Active comparator | Drug: Insulin Lispro Protamine SuspensionInsulin Lispro Protamine Suspension (ILPS) |
| Glargine | Active comparator | Drug: Insulin GlargineInsulin Glargine |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Key exclusion criteria (5 listed)
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of 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 Protamine SuspensionAlso: LY275585[P]Administered subcutaneously once a day at bedtime | Drug | ILPS |
| Insulin GlargineAlso: LantusAdministered subcutaneously once a day at bedtime | Drug | Glargine |
Primary outcome
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Time frame: Baseline, Endpoint (LOCF) up to 24 weeks
Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
10 secondary outcomes
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Time frame: 24 weeks, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Time frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Time frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Time frame: Baseline, Endpoint (LOCF) up to 24 weeks
Glycemic Variability at Baseline and Endpoint (LOCF)
Time frame: Baseline, Endpoint (LOCF) up to 24 weeks
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Time frame: Baseline to Endpoint (LOCF) up to 24 weeks
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Time frame: Baseline to Endpoint (LOCF) up to 24 weeks
Actual Body Weight at Baseline and Endpoint (LOCF)
Time frame: Baseline, Endpoint (LOCF) up to 24 weeks
Change From Baseline in Body Weight at Endpoint (LOCF)
Time frame: Baseline, Endpoint (LOCF) up to 24 weeks
Total Daily Insulin Dose at Endpoint (LOCF)
Time frame: Endpoint (LOCF) up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Lispro Protamine Suspension and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 52 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 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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 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?
Yes. Results are posted in the registry (first posted 14 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF]) (time frame: Baseline, Endpoint (LOCF) up to 24 weeks). 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 13 Jan 2011.