Diabetes Mellitus Type 2Phase 3IOOYNCT00494013
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
A Phase 3 study testing Insulin Lispro Protamine Suspension and Detemir in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 56 sites in 9 countries.
Trial summary
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Insulin Lispro Protamine Suspension and Detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 56 sitesin 9 countries
- Study dates
- Aug 2007to Sep 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Who cannot join
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Trial locations and contacts
56 sites in 9 countries.
56 sites in 9 countries
United States27 sites
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Atlanta, Georgia, 30312
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Bend, Oregon, 97701
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Buena Park, California, 90620
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45236
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Evansville, Indiana, 47714
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Fountain Valley, California, 92708
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Goldsboro, North Carolina, 27530
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Grand Prairie, Texas, 75052
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Hueytown, Alabama, 35023
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Indianapolis, Indiana, 46202
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Jacksonville, Florida, 32257
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Johnson City, Tennessee, 37604
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Lansdale, Pennsylvania, 19446
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Las Vegas, Nevada, 89101
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Lexington, Kentucky, 40503
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Litchfield Park, Arizona, 85340
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London, Ohio, 43140
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Los Angeles, California, 90057
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Menomonee Falls, Wisconsin, 53051
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Newburgh, Indiana, 47630
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Novi, Michigan, 48374
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Phoenix, Arizona, 85016
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Prince Frederick, Maryland, 20678
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Slidell, Louisiana, 70458
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Syracuse, New York, 13210
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Taylors, South Carolina, 29687
Hungary6 sites
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Budapest, H-1139
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Eger, 3300
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Makó, 6900
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Székesfehérvár, 8000
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Szekszárd, 7100
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Veszprém, 8200
India5 sites
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Bangalore, 560052
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Chennai, 600086
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Kochi, 682026
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Mumbai, 400 067
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Pune, 411011
Taiwan5 sites
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Chiayi City, 600
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Neihu Taipei, 114
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Tainan, 704
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Taipei, 100
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Yung-Kang, Tainan, 710
Spain4 sites
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Lugo, 27004
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Palma de Mallorca, 07014
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Santa Cruz de Tenerife, 38320
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Valencia, 46015
Poland3 sites
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Krakow, 30-349
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Poznan, 61-495
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Rzeszów, 35-068
Argentina2 sites
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Buenos Aires, C1188AAF
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Ramos Mejía, B1704ETD
Mexico2 sites
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Chihuahua City, 31238
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Guadalajara, 44340
South Korea2 sites
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Goyang-si, 410-719
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Sungnam-Si, 463-712
About this study
Official title: Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Insulin Lispro Protamine Suspension, Detemir
- Keywords
- diabetes, type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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 Neutral Protamine Lispro (NPL), Humalog, ILPS
Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirDrug
Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Insulin Lispro Protamine Suspension | Experimental | Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. Receives: Drug: Insulin Lispro Protamine Suspension |
| Detemir | Active comparator | Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks. Receives: Drug: Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Measured: Baseline, 24 Weeks
Secondary outcomes (11)
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Measured: Baseline, 12 Weeks, 24 Weeks
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
Measured: 24 Weeks
Glycemic Variability
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose [SMBG] profiles at endpoint) for the actual morning pre-meal blood glucose value.
Measured: 24 Weeks
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Actual daily mean blood glucose levels at endpoint.
Measured: 24 Weeks
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Results are for the combined titration and maintenance periods.
Measured: Baseline to 24 Weeks
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
Measured: Baseline to 24 Weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
Measured: Baseline to 24 Weeks
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Measured: Baseline, 24 Weeks
Total Daily Insulin Dose (Units) at Endpoint
Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
Measured: 24 Weeks
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (Units/kilograms).
Measured: 24 Weeks
Number of Injections of Basal Insulin Analog at Endpoint
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 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
- NCT00494013
- Sponsor's protocol ID
- 10935
- Other IDs
- F3Z-MC-IOOY
- Acronym
- IOOY
- Status last verified
- Nov 2009
- First submitted
- 27 Jun 2007
- Last updated
- 11 Nov 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
PubMed 23101951Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
PubMed 20546262
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00494013
- Acronym / sponsor ID
- IOOY / 10935
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes, type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Posted 4 Nov 2009
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 examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Lispro Protamine Suspension | Experimental | Drug: Insulin Lispro Protamine SuspensionInsulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. |
| Detemir | Active comparator | Drug: DetemirDetemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have type 2 diabetes mellitus for at least 1 year.
- Are at least 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Key exclusion criteria (5 listed)
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
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: Neutral Protamine Lispro (NPL), Humalog, ILPSPatient specific dose administered subcutaneously once daily or twice daily x 24 weeks. | Drug | Insulin Lispro Protamine Suspension |
| DetemirPatient specific dose administered subcutaneously once or twice daily x 24 weeks. | Drug | Detemir |
Primary outcome
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 24 Weeks
11 secondary outcomes
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Time frame: Baseline, 12 Weeks, 24 Weeks
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
Time frame: 24 Weeks
Glycemic Variability
Time frame: 24 Weeks
7-point Self-monitored Blood Glucose (SMBG) Profile at Endpoint
Time frame: 24 Weeks
Number of Participants With Self-reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall for All Study Periods
Time frame: Baseline to 24 Weeks
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Time frame: Baseline to 24 Weeks
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Time frame: Baseline to 24 Weeks
Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Time frame: Baseline, 24 Weeks
Total Daily Insulin Dose (Units) at Endpoint
Time frame: 24 Weeks
Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
Time frame: 24 Weeks
Number of Injections of Basal Insulin Analog at Endpoint
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23101951Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Derived from this study: PubMed 20546262Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.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
56 sites in 9 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 Detemir in people with Diabetes Mellitus Type 2, run by Eli Lilly and Company at 56 sites in 9 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 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Hungary, India, Taiwan, Spain and 4 more countries. 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 4 Nov 2009). 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 to 24 Week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 Weeks). 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 NCT00494013, 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 11 Nov 2009.