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A Study in Participants With Type I Diabetes Mellitus (IMAGINE 3)

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Glargine

LY2605541

Insulin Lispro

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 1 diabetes for at least 1 year
HbA1c value less than 12 percent according to the central laboratory at screening
Body mass index of 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
- insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in combination with pre-meal insulin, or
- self-mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
- continuous SC insulin infusion therapy
Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 2 weeks after last treatment with study drug
Are capable and willing to adhere to multiple daily injections, inject with a vial and syringe and prefilled pen and perform self-monitored blood glucose (SMBG) readings and record keeping

Exclusion Criteria:

Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening
Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (U/kg) at the time of randomization
Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening
Lipid lowering medications:
- are using niacin preparations as 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 90 days or more prior to screening
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) within 6 months prior to screening
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within 6 months prior to screening
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 2.5 mg/dL
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 2 times or more than the upper limit of normal (ULN) as defined by the central laboratory, or
- alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more than 2.5 times ULN as defined by the central laboratory, or
- aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) more than 2.5 times ULN as defined by the central laboratory
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 increased risk for developing cancer or a recurrence of cancer
Diagnosed clinically significant diabetic autonomic neuropathy

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY2605541 + Insulin Lispro

Glargine + Insulin Lispro

Arm Description

LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

Glargine dose titrated based on blood glucose readings, administered SC once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

Outcomes

Primary Outcome Measures

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 treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

Secondary Outcome Measures

Hemoglobin A1c (HbA1c)

HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

Change From Baseline to 52 Weeks in 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 (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

Total Hypoglycemia Events

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 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.

Percentage of Participants With Total Hypoglycemic Events

Hypoglycemic episodes are defined as events that are associated with the 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, multiplied by 100.

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.

Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia

Hypoglycemic episodes are defined as events 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 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, multiplied by 100.

Nocturnal Hypoglycemia Rates

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.

Percentage of Participants With Nocturnal Hypoglycemic Events

Hypoglycemic episodes are defined as events associated with the 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, multiplied by 100.

Change in Body Weight

LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect.

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, and 52. 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 subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline BG values as the fixed effects and participant as the random effect.

Fasting Serum Glucose (by Laboratory Measurement)

Fasting serum glucose (FSG) is measured in blood before the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)

Fasting blood glucose (FBG) was measured by SMBG pre-morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline FBG as the fixed effects and participant as the random effect.

Intra-participant Variability of Fasting Blood Glucose (FBG)

FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation (SD) of FBG. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline SD of FBG as the fixed effects and participant as the random effect.

0300 Hours Blood Glucose (BG) to Fasting BG Excursion

Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only excursions within a single SMBG profile are included). LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline excursion as the fixed effects and participant as the random effect.

Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol

Concentrations of cholesterol, HDL-C, and LDL-C, and triglycerides are presented. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L), except for the LDL-C outcome variable], prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable as the fixed effects and participant as a random effect.

Percentage of Participants With Change in Anti-LY2605541 Antibodies

The percentage of participants with anti-LY2605541 treatment-emergent 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.

Basal, Meal Time, and Total Insulin Dose Per Body Weight

Basal insulin dose, meal-time insulin dose (short-acting bolus dose), 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 a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each postbaseline visit and stratification variables (baseline HbA1c [≤8.5% and> 8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], and baseline prior basal insulin therapy [insulin glargine/detemir/ other]) as fixed effects.

Insulin Treatment Satisfaction Questionnaire

Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated measure containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Convenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data are transformed to a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an ANCOVA model adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, and baseline prior basal insulin therapy (insulin glargine/detemir/other) as fixed effects and baseline ITSQ scores as a covariate.

European Quality of Life -5 Dimension (EQ-5D-3L)

The EQ-5D-3L 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 three-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 ANCOVA adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), and baseline EQ-5D-3L score as covariates.

Adult Low Blood Sugar Survey

Low Blood Sugar Survey (LBSS) (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 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-type 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, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), visit, treatment-by-visit interaction, and baseline LBSS score as the fixed effects and participant as the random effect.

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 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 activity, either strength or flexibility activity (not both), both strength and flexibility 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, multiplied by 100.

Full Information

NCT ID

NCT01454284

First Posted

October 14, 2011

Last Updated

March 16, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01454284

Brief Title

A Study in Participants With Type I Diabetes Mellitus

Acronym

IMAGINE 3

Official Title

The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is: To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 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 52 weeks of treatment. To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2605541 + Insulin Lispro

Arm Type

Experimental

Arm Description

Arm Title

Glargine + Insulin Lispro

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Glargine

Intervention Type

Drug

Intervention Name(s)

LY2605541

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

LY275585, Humalog

Primary Outcome Measure Information:

Title

Hemoglobin A1c (HbA1c)

Description

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Hemoglobin A1c (HbA1c)

Description

Time Frame

26 weeks

Title

Change From Baseline to 52 Weeks in HbA1c

Description

Time Frame

Baseline, 52 weeks

Title

Total Hypoglycemia Events

Description

Time Frame

Baseline through 26 weeks, Baseline through 52 weeks

Title

Percentage of Participants With Total Hypoglycemic Events

Description

Time Frame

Baseline through 26 weeks, Baseline through 52 weeks

Title

Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%

Description

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.

Time Frame

up to 26 weeks, up to 52 weeks

Title

Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia

Description

Time Frame

up to 26 weeks, up to 52 weeks

Title

Nocturnal Hypoglycemia Rates

Description

Time Frame

Baseline through 26 weeks, Baseline through 52 weeks

Title

Percentage of Participants With Nocturnal Hypoglycemic Events

Description

Time Frame

Baseline through 26 weeks, Baseline through 52 weeks

Title

Change in Body Weight

Description

Time Frame

Baseline, 26 weeks, 52 weeks

Title

9 Point Self-monitored Blood Glucose (SMBG)

Description

Time Frame

26 weeks and 52 weeks

Title

Fasting Serum Glucose (by Laboratory Measurement)

Description

Time Frame

26 weeks and 52 weeks

Title

Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)

Description

Time Frame

26 weeks and 52 weeks

Title

Intra-participant Variability of Fasting Blood Glucose (FBG)

Description

Time Frame

26 weeks and 52 weeks

Title

0300 Hours Blood Glucose (BG) to Fasting BG Excursion

Description

Time Frame

26 weeks and 52 weeks

Title

Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol

Description

Time Frame

26 weeks and 52 weeks

Title

Percentage of Participants With Change in Anti-LY2605541 Antibodies

Description

Time Frame

26 weeks, 52 weeks

Title

Basal, Meal Time, and Total Insulin Dose Per Body Weight

Description

Time Frame

26 weeks and 52 weeks

Title

Insulin Treatment Satisfaction Questionnaire

Description

Time Frame

up to 52 weeks

Title

European Quality of Life -5 Dimension (EQ-5D-3L)

Description

Time Frame

up to 52 weeks

Title

Adult Low Blood Sugar Survey

Description

Time Frame

26 weeks and 52 weeks

Title

Rapid Assessment of Physical Activity (RAPA)

Description

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes for at least 1 year HbA1c value less than 12 percent according to the central laboratory at screening Body mass index of 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 insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in combination with pre-meal insulin, or self-mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or continuous SC insulin infusion therapy Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 2 weeks after last treatment with study drug Are capable and willing to adhere to multiple daily injections, inject with a vial and syringe and prefilled pen and perform self-monitored blood glucose (SMBG) readings and record keeping Exclusion Criteria: Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (U/kg) at the time of randomization Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening Lipid lowering medications: are using niacin preparations as 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 90 days or more prior to screening 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) within 6 months prior to screening Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within 6 months prior to screening 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 2.5 mg/dL 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 2 times or more than the upper limit of normal (ULN) as defined by the central laboratory, or alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more than 2.5 times ULN as defined by the central laboratory, or aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) more than 2.5 times ULN as defined by the central laboratory 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 increased risk for developing cancer or a recurrence of cancer Diagnosed clinically significant diabetic autonomic neuropathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32258

Country

United States

Facility Name

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67226

Country

United States

Facility Name

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55123

Country

United States

Facility Name

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27713

Country

United States

Facility Name

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37411

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77095

Country

United States

Facility Name

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

City

Ogden

State/Province

Utah

ZIP/Postal Code

84403

Country

United States

Facility Name

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

City

Merewether

State/Province

New South Wales

ZIP/Postal Code

2291

Country

Australia

Facility Name

City

Keswick

State/Province

South Australia

ZIP/Postal Code

5035

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Huy

ZIP/Postal Code

4500

Country

Belgium

Facility Name

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

City

Fortaleza

ZIP/Postal Code

60430-350

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

91350250

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5J 3N4

Country

Canada

Facility Name

City

Red Deer

State/Province

Alberta

ZIP/Postal Code

T4N 6V7

Country

Canada

Facility Name

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6H 3P1

Country

Canada

Facility Name

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

City

Kobenhavn

ZIP/Postal Code

2400

Country

Denmark

Facility Name

City

La Rochelle

ZIP/Postal Code

17019

Country

France

Facility Name

City

Le Creuzot

ZIP/Postal Code

71200

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75022

Country

France

Facility Name

City

Rouen

ZIP/Postal Code

76031

Country

France

Facility Name

City

Athens

ZIP/Postal Code

10552

Country

Greece

Facility Name

City

Chalkida

ZIP/Postal Code

341 00

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

City

Dublin

Country

Ireland

Facility Name

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

City

Petah Tiqva

ZIP/Postal Code

49451

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

City

Jonava

ZIP/Postal Code

LT-55201

Country

Lithuania

Facility Name

City

Kaunas

ZIP/Postal Code

LT-51270

Country

Lithuania

Facility Name

City

Dordrecht

ZIP/Postal Code

3317 NM

Country

Netherlands

Facility Name

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

City

Christchurch

ZIP/Postal Code

8001

Country

New Zealand

Facility Name

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Katowice

ZIP/Postal Code

40-057

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

31-261

Country

Poland

Facility Name

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-507

Country

Poland

Facility Name

City

Sturovo

ZIP/Postal Code

943 01

Country

Slovakia

Facility Name

City

Houghton

ZIP/Postal Code

2198

Country

South Africa

Facility Name

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

City

Alcala De Henares

ZIP/Postal Code

28805

Country

Spain

Facility Name

City

Alcira

ZIP/Postal Code

46600

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29006

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

City

Seville

ZIP/Postal Code

41003

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

City

Alingsås

ZIP/Postal Code

44183

Country

Sweden

Facility Name

City

Helsingborg

ZIP/Postal Code

25187

Country

Sweden

Facility Name

City

Huddinge

ZIP/Postal Code

14186

Country

Sweden

Facility Name

City

Karlstad

ZIP/Postal Code

SE-651 85

Country

Sweden

Facility Name

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

City

Portsmouth

State/Province

Hampshire

ZIP/Postal Code

P06 3LY

Country

United Kingdom

Facility Name

City

Blackburn

State/Province

Lancashire

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

City

Leicester

State/Province

Leicestershire

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

City

Inverness

State/Province

Scotland

ZIP/Postal Code

IV2 3JH

Country

United Kingdom

Facility Name

City

Ipswich

State/Province

Suffolk

ZIP/Postal Code

IP4 5PD

Country

United Kingdom

Facility Name

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

City

Swansea

State/Province

Wales

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

Facility Name

City

Glasgow

ZIP/Postal Code

G21 3UW

Country

United Kingdom

Facility Name

City

Northampton

ZIP/Postal Code

NN1 5BD

Country

United Kingdom

Facility Name

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29167192

Citation

Sanyal 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.

Results Reference

derived

PubMed Identifier

28587667

Citation

Orchard 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.

Results Reference

derived

PubMed Identifier

28417532

Citation

Cusi 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.

Results Reference

derived

Learn more about this trial

A Study in Participants With Type I Diabetes Mellitus

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