Diabetes Mellitus, Type 1Phase 3IMAGINE 1NCT01481779
A Study in Participants With Type 1 Diabetes Mellitus
A Phase 3 study testing Glargine, LY2605541 and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 51 sites in 9 countries.
Trial summary
The purpose of this study is: To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Glargine, LY2605541 and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 51 sitesin 9 countries
- Study dates
- Jan 2012to Jun 2014
- 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 diabetes mellitus for at least 1 year
- Have an hemoglobin A1c (HbA1c) value less than 12% according to the central laboratory at screening
- Have a body mass index (BMI) less than or equal to 35.0 kilograms per square meter (kg/m^2)
- Have been treated for at least 90 days prior to screening with the following:
- Insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin,
- Self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
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- Continuous SC insulin infusion therapy
- This inclusion criterion applies to female participants:
- Are not breastfeeding
- Test negative for pregnancy at screening and randomization based on serum pregnancy tests
- Do not intend to become pregnant during the study
- Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) for at least 6 weeks prior to screening
- Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
- Capable of and willing and desirous to do the following: adhere to a multiple daily injection regimen, inject insulin with a prefilled pen and perform Self-Monitored Blood Glucose (SMBG) and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above.
Who cannot join
- Are using twice-daily insulin glargine having been inadequately controlled on once-daily dosed glargine prior to screening
- Have excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (units/kg) at the time of randomization
- Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening
- Lipid-lowering medications:
- Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or are using lipid-lowering medication at a dose that has not been stable for greater than or equal to 90 days prior to screening
- If a participant has not been on a stable dose of lipid-lowering medication for greater than or equal to 90 days prior to screening, the site should wait to screen the participant. If the results of the screening laboratory tests require a change to the participant's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the participant and to have the participant return greater than or equal to 90 days later to complete some of the screening procedures again
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- Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as determined by the central laboratory
- Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia as determined by the investigator) within 6 months prior to entry into the study
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
- Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
- Renal: Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
- Hepatic: 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 as indicated below:
- Total bilirubin greater than or equal to 2 times the upper limit of normal (ULN) as defined by the central laboratory,
- Alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times ULN as defined by the central laboratory, or
- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN as defined by the central laboratory.
- Malignancy: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Allergy: Have known hypersensitivity or allergy to any of the study insulins or their excipients
- Hematologic: Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
- Glucocorticoid therapy: Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical , intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
- Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
- Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States12 sites
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Aurora, Colorado, 80010
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Concord, California, 94520
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Escondido, California, 92026
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Fresno, California, 93720
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Greenbrae, California, 94904
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Huntington Beach, California, 92648
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Idaho Falls, Idaho, 83404
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Las Vegas, Nevada, 89148
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Renton, Washington, 98057
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Salt Lake City, Utah, 84102
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San Mateo, California, 94401
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Spokane, Washington, 99202
Germany9 sites
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Berlin, 10409
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Eisenach, 99817
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Falkensee, 14612
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Hamburg, 22559
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Mainz, 55116
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Mayen, 56727
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Münster, 48153
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Neuwied, 56564
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Pohlheim, 35415
France8 sites
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Bar-le-Duc, 55000
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Corbeil-Essonnes, 91100
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Montpellier, 34295
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Nantes, 44093
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Nice, 06002
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Saint-Mandé, 94160
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Toulouse, 31059
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Vénissieux, 69200
Italy6 sites
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Cagliari, 09100
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Catania, 95100
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Lecce, 73100
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Padova, 35128
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Perugia, 06100
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Ravenna, 48100
Japan4 sites
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Hokkaido, 060-0002
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Kanagawa, 235-0045
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Kumamoto, 862-0976
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Tokyo, 162-8666
Poland4 sites
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Katowice, 40-057
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Lodz, 93-338
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Poznan, 61-655
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Warsaw, 01-192
Mexico3 sites
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Guadalajara, 44150
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Guadalajara Jalisco, 04460
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Monterrey, 64460
Russia3 sites
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Arkhangelsk, 163045
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Moscow, 119991
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Saint Petersburg, 193257
Austria2 sites
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Graz, 8036
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Vienna, 1130
About this study
Official title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study
The purpose of this study is:
- To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
- To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
- To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
- To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Glargine, LY2605541, Insulin Lispro
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlargineDrug
Administered by SC injection via a pen device.
LY2605541Drug
Administered by SC injection with a pen device.
Insulin LisproDrug
Also called LY275585, Humalog
Administered by SC injection with a pen device.
| Study group | Role | What they receive |
|---|---|---|
| LY2605541 + Insulin Lispro | Experimental | LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. Receives: Drug: LY2605541; Drug: Insulin Lispro |
| Glargine + Insulin Lispro | Active comparator | Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. Receives: Drug: Glargine; Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) at 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 treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Measured: 26 weeks
Secondary outcomes (20)
Hemoglobin A1c (HbA1c)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Measured: 52 weeks and 78 weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.
Measured: Baseline, 26 weeks, 52 weeks, 78 weeks
Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.
Measured: 26 weeks and 52 weeks and 78 weeks
Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. 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, then multiplying by 100.
Measured: 26 weeks and 52 weeks and 78 weeks
Total Hypoglycemia Rates (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, 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 and Baseline through 78 weeks
Percentage of Participants With Total Hypoglycemia Events
Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Measured: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, 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 and Baseline through 78 weeks
Percentage of Participants With Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.
Measured: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Fasting Serum Glucose (FSG) by Laboratory Measurement
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
Fasting Blood Glucose (FBG) Intra-participant Variability
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 treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
9 Point Self-monitored Blood Glucose (SMBG)
9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
Change From Baseline in Body Weight
LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.
Measured: Baseline and 26 weeks and 52 weeks and 78 weeks
Basal, Bolus, and Total Insulin Dose
Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
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 (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.
Measured: 26 weeks and 52 weeks and 78 weeks
Percentage of Participants With Change in Anti-LY2605541 Antibodies
The percentage 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 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ)
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, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate.
Measured: 26 weeks
Low Blood Sugar Survey (LBSS)
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 MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.
Measured: 26 weeks and 52 weeks and 78 weeks
European Quality of Life-5 Dimension (EQ-5D)
The EQ-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 ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate.
Measured: 26 weeks
Rapid Assessment of Physical Activity (RAPA)
The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
Measured: 26 weeks and 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionJun 2014
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 (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 455 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
- NCT01481779
- Sponsor's protocol ID
- 12146
- Other IDs
- I2R-MC-BIAN, 2011-001261-40
- Acronym
- IMAGINE 1
- Status last verified
- Mar 2018
- First submitted
- 28 Nov 2011
- Last updated
- 17 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 28417532
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study
- ClinicalTrials.gov ID
- NCT01481779
- Acronym / sponsor ID
- IMAGINE 1 / 12146
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 17 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 the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
- To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
- To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
- To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2605541 + Insulin Lispro | Experimental | Drug: LY2605541, Drug: Insulin LisproLY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. |
| Glargine + Insulin Lispro | Active comparator | Drug: Glargine, Drug: Insulin LisproGlargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have had diabetes mellitus for at least 1 year
- Have an hemoglobin A1c (HbA1c) value less than 12% according to the central laboratory at screening
- Have a body mass index (BMI) less than or equal to 35.0 kilograms per square meter (kg/m^2)
- Have been treated for at least 90 days prior to screening with the following:
- This inclusion criterion applies to female participants:
Key exclusion criteria (21 listed)
- Are using twice-daily insulin glargine having been inadequately controlled on once-daily dosed glargine prior to screening
- Have excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (units/kg) at the time of randomization
- Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening
- Lipid-lowering medications:
- Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as determined by the central 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 |
|---|---|---|
| GlargineAdministered by SC injection via a pen device. | Drug | Glargine + Insulin Lispro |
| LY2605541Administered by SC injection with a pen device. | Drug | LY2605541 + Insulin Lispro |
| Insulin LisproAlso: LY275585, HumalogAdministered by SC injection with a pen device. | Drug | Glargine + Insulin Lispro, LY2605541 + Insulin Lispro |
Primary outcome
Hemoglobin A1c (HbA1c) at 26 Weeks
Time frame: 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 treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
20 secondary outcomes
Hemoglobin A1c (HbA1c)
Time frame: 52 weeks and 78 weeks
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 26 weeks, 52 weeks, 78 weeks
Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
Time frame: 26 weeks and 52 weeks and 78 weeks
Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
Time frame: 26 weeks and 52 weeks and 78 weeks
Total Hypoglycemia Rates (Adjusted by 30 Days)
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Percentage of Participants With Total Hypoglycemia Events
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Percentage of Participants With Nocturnal Hypoglycemic Events
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Fasting Serum Glucose (FSG) by Laboratory Measurement
Time frame: 26 weeks and 52 weeks and 78 weeks
Fasting Blood Glucose (FBG) Intra-participant Variability
Time frame: 26 weeks and 52 weeks and 78 weeks
0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
Time frame: 26 weeks and 52 weeks and 78 weeks
9 Point Self-monitored Blood Glucose (SMBG)
Time frame: 26 weeks and 52 weeks and 78 weeks
Change From Baseline in Body Weight
Time frame: Baseline and 26 weeks and 52 weeks and 78 weeks
Basal, Bolus, and Total Insulin Dose
Time frame: 26 weeks and 52 weeks and 78 weeks
Lipid Profile
Time frame: 26 weeks and 52 weeks and 78 weeks
Percentage of Participants With Change in Anti-LY2605541 Antibodies
Time frame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ)
Time frame: 26 weeks
Low Blood Sugar Survey (LBSS)
Time frame: 26 weeks and 52 weeks and 78 weeks
European Quality of Life-5 Dimension (EQ-5D)
Time frame: 26 weeks
Rapid Assessment of Physical Activity (RAPA)
Time frame: 26 weeks and 78 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
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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
51 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 Glargine, LY2605541 and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 51 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 14 inclusion and 21 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 17 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 51 sites in United States, Germany, France, Italy, Japan 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 17 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?
Hemoglobin A1c (HbA1c) at 26 Weeks (time frame: 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 NCT01481779, which also lists 4 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 17 Apr 2018.