Diabetes Mellitus, Type 2Phase 3IMAGINE 5NCT01582451
A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
A Phase 3 study testing LY2605541 and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 61 sites in 9 countries.
Trial summary
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks: Change in participants' overall blood sugar control The rate of night time low blood sugar episodes The number of participants that reach blood sugar targets without… 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?
- LY2605541 and Insulin 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
- 466 participants
- Where
- 61 sitesin 9 countries
- Study dates
- May 2012to Dec 2013
- 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 had type 2 diabetes mellitus for at least 1 year
- Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
- Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Who cannot join
- Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
- Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
- Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
Show all 17Show fewer
- Have cardiac disease with functional status that is New York Heart Association Class III or IV
- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L])
- Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- Lipid-lowering medication: Are using or have used any of the following:
- niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
- lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
Trial locations and contacts
61 sites in 9 countries.
61 sites in 9 countries
United States33 sites
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Akron, Ohio, 44304
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Austin, Texas, 78731
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Bangor, Maine, 04401
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Bloomington, Indiana, 47402
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Bountiful, Utah, 84010
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Chicago, Illinois, 60607
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Concord, California, 94520
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Crystal Lake, Illinois, 60012
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Dallas, Texas, 75251
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Delaware, Ohio, 43015
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Durham, North Carolina, 27713
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Escondido, California, 92026
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Federal Way, Washington, 98003
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Fort Lauderdale, Florida, 33316
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Fresno, California, 93720
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Jackson, Tennessee, 38305
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Memphis, Tennessee, 38119
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Mesa, Arizona, 85213
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Miami, Florida, 33175
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Milwaukee, Wisconsin, 53226
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Nashua, New Hampshire, 03063
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New Port Richey, Florida, 34652
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Olympia, Washington, 98502
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Oviedo, Florida, 32765
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Phoenix, Arizona, 85050
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Raleigh, North Carolina, 27609
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Rockville, Maryland, 20852
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Roswell, Georgia, 30076
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Round Rock, Texas, 78681
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Spring Valley, California, 91978
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Springfield, Missouri, 65807
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Toms River, New Jersey, 08753
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Topeka, Kansas, 66606
Germany5 sites
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Aschaffenburg, 63739
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Bad Mergentheim, 97980
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Damme, 49401
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Dresden, 01307
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Rhaunen, 55624
Israel5 sites
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Acre, 18274
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Beersheba, 84350
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Holon, 58100
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Nazareth, 16000
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Raanana, 43452
Spain5 sites
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Alzira, 46600
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Cadiz, 11540
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Palma de Mallorca, 07010
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Pozuelo de Alarcón, 28223
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Teruel, 44001
Czechia3 sites
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Beroun, 26601
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Brandýs nad Labem, 250 01
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Prague, 181 00
Romania3 sites
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Bucharest, 020359
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Oradea, 410169
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Sibiu, 550245
Russia3 sites
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Arkhangelsk, 163045
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Novosibirsk, 630091
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Saint Petersburg, 192012
Greece2 sites
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Chalcis, 341 00
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Thessaloniki, 54639
Puerto Rico2 sites
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Bayamón, 00961
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Ponce, 00717
About this study
Official title: A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low blood sugar episodes at night
- The rate of low blood sugar episodes reported over a 24-hour period
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2605541, 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.
LY2605541Drug
Also called Insulin peglispro
Insulin glargineDrug
| Study group | Role | What they receive |
|---|---|---|
| LY2605541 | Experimental | Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks. Receives: Drug: LY2605541 |
| Insulin glargine | Active comparator | Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks. Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Measured: Baseline, 26 weeks
Secondary outcomes (18)
Change From Baseline to 52 Weeks in HbA1c
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Measured: Baseline, 52 weeks
Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Measured: Baseline through 26 weeks and Baseline through 52 weeks
Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Measured: Baseline through 26 weeks and Baseline through 52 weeks
Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Measured: 26 and 52 weeks
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.
Measured: 26 and 52 weeks
Fasting Serum Glucose (FSG) (by Laboratory)
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.
Measured: 26 and 52 weeks
Fasting Blood Glucose (FBG) (by Self Monitoring)
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.
Measured: 26 and 52 weeks
Intra-participant Variability in Fasting Blood Glucose (FBG)
FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.
Measured: 26 and 52 weeks
6-point Self-monitored Blood Glucose (SMBG)
SMBG measurements were taken at 6 time points (pre-morning meal [fasting], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal [fasting] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.
Measured: 26 and 52 weeks
HbA1c
LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Measured: 26 and 52 weeks
Insulin Dose Per Kilogram of Body Weight
Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.
Measured: 26 and 52 weeks
Number of Insulin Dose Adjustments to Steady-state
The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use).
Measured: Baseline through 26 weeks
European Quality of Life - 5 Dimension (EuroQol-5D) Score
The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use), and baseline EuroQol-5D score.
Measured: 26 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.
Measured: 26 weeks
Adult Low Blood Sugar Survey (LBSS) Score
LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.
Measured: 26 weeks
Change From Baseline in Body Weight
LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.
Measured: Baseline, 26 weeks, 52 weeks
Change From Baseline in Lipid Profile
Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
Measured: Baseline, 26 weeks, 52 weeks
Number of Participants With Change in Anti-LY2605541 Antibodies
The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.
Measured: Baseline through 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionDec 2013
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 (5)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
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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
- NCT01582451
- Sponsor's protocol ID
- 14703
- Other IDs
- I2R-MC-BIDJ
- Acronym
- IMAGINE 5
- Status last verified
- Mar 2018
- First submitted
- 19 Apr 2012
- Last updated
- 20 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
PubMed 36542287Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
PubMed 29167192Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
PubMed 28587667Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
PubMed 28417532Buse JB, Rodbard HW, Trescoli Serrano C, Luo J, Ivanyi T, Bue-Valleskey J, Hartman ML, Carey MA, Chang AM; IMAGINE 5 Investigators. Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5. Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.
PubMed 26577417
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study
- ClinicalTrials.gov ID
- NCT01582451
- Acronym / sponsor ID
- IMAGINE 5 / 14703
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 20 Apr 2018
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 LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low blood sugar episodes at night
- The rate of low blood sugar episodes reported over a 24-hour period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2605541 | Experimental | Drug: LY2605541Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks. |
| Insulin glargine | Active comparator | Drug: Insulin glargineAdministered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 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 had type 2 diabetes mellitus for at least 1 year
- Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
- Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Key exclusion criteria (17 listed)
- Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
- Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia within 6 months prior to screening
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 |
|---|---|---|
| LY2605541Also: Insulin peglispro | Drug | LY2605541 |
| Insulin glargine | Drug | Insulin glargine |
Primary outcome
Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 26 weeks
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
18 secondary outcomes
Change From Baseline to 52 Weeks in HbA1c
Time frame: Baseline, 52 weeks
Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)
Time frame: Baseline through 26 weeks and Baseline through 52 weeks
Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events
Time frame: Baseline through 26 weeks and Baseline through 52 weeks
Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%
Time frame: 26 and 52 weeks
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
Time frame: 26 and 52 weeks
Fasting Serum Glucose (FSG) (by Laboratory)
Time frame: 26 and 52 weeks
Fasting Blood Glucose (FBG) (by Self Monitoring)
Time frame: 26 and 52 weeks
Intra-participant Variability in Fasting Blood Glucose (FBG)
Time frame: 26 and 52 weeks
6-point Self-monitored Blood Glucose (SMBG)
Time frame: 26 and 52 weeks
HbA1c
Time frame: 26 and 52 weeks
Insulin Dose Per Kilogram of Body Weight
Time frame: 26 and 52 weeks
Number of Insulin Dose Adjustments to Steady-state
Time frame: Baseline through 26 weeks
European Quality of Life - 5 Dimension (EuroQol-5D) Score
Time frame: 26 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
Time frame: 26 weeks
Adult Low Blood Sugar Survey (LBSS) Score
Time frame: 26 weeks
Change From Baseline in Body Weight
Time frame: Baseline, 26 weeks, 52 weeks
Change From Baseline in Lipid Profile
Time frame: Baseline, 26 weeks, 52 weeks
Number of Participants With Change in Anti-LY2605541 Antibodies
Time frame: Baseline through 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36542287Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
- Derived from this study: PubMed 29167192Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
- Derived from this study: PubMed 28587667Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
- Derived from this study: PubMed 28417532Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
- Derived from this study: PubMed 26577417Buse JB, Rodbard HW, Trescoli Serrano C, Luo J, Ivanyi T, Bue-Valleskey J, Hartman ML, Carey MA, Chang AM; IMAGINE 5 Investigators. Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5. Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.
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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
61 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 LY2605541 and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 61 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 17 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Germany, Israel, Spain, Czechia 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 20 Apr 2018). 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 26-week Endpoint in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 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 NCT01582451, which also lists 5 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 20 Apr 2018.