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Study of LY2409021 in Participants With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

LY2409021

Placebo

Glucagon

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2)
Have given written informed consent approved by Lilly

Exclusion Criteria:

Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
Are pregnant or intend to become pregnant during the course of the study
Women who are breastfeeding
Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter [mmol/L])
Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase [ALT] or aspartate transaminase [AST] greater than 2 times the upper limit of normal at screening)
Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine >2.0 mg/dL (177 micromoles per liter [μmol/L])
Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

100 mg LY2409021

300 mg LY2409021

Placebo

Arm Description

LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3.

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3.

Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Outcomes

Primary Outcome Measures

Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose

The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.

Secondary Outcome Measures

Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin

The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.

Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021

Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.

Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period

Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia

Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3

The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.

Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3

Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.

Full Information

NCT ID

NCT01640834

First Posted

July 12, 2012

Last Updated

March 24, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01640834

Brief Title

Study of LY2409021 in Participants With Type 1 Diabetes

Official Title

Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.

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 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100 mg LY2409021

Arm Type

Experimental

Arm Description

Arm Title

300 mg LY2409021

Arm Type

Experimental

Arm Description

LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Intervention Type

Drug

Intervention Name(s)

LY2409021

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Glucagon

Intervention Description

Administered via intramuscular injection

Primary Outcome Measure Information:

Title

Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose

Description

The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.

Time Frame

Baseline (Day 1), Day 2

Secondary Outcome Measure Information:

Title

Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin

Description

The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.

Time Frame

Baseline (Day 1), Day 2

Title

Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021

Time Frame

Predose (Day 2) through 120 hours postdose (Day 7)

Title

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021

Description

Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.

Time Frame

Predose (Day 2) through 120 hours postdose (Day 7)

Title

Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period

Description

Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

Time Frame

Baseline (Day 1), Day 3 up to Day 6

Title

Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia

Description

Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.

Time Frame

Baseline (Day 1), Day 3 up to Day 6

Title

Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3

Description

The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.

Time Frame

Day 3

Title

Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3

Description

Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.

Time Frame

Day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2) Have given written informed consent approved by Lilly Exclusion Criteria: Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness Are pregnant or intend to become pregnant during the course of the study Women who are breastfeeding Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter [mmol/L]) Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase [ALT] or aspartate transaminase [AST] greater than 2 times the upper limit of normal at screening) Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine >2.0 mg/dL (177 micromoles per liter [μmol/L]) Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

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

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

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Study of LY2409021 in Participants With Type 1 Diabetes

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