Study of LY2409021 in Participants With Type 1 Diabetes

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

Sponsors

Lead Sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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.

Overall Status Completed
Start Date July 2012
Completion Date September 2012
Primary Completion Date September 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose Baseline (Day 1), Day 2
Secondary Outcome
Measure Time Frame
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin Baseline (Day 1), Day 2
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3 Day 3
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3 Day 3
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: LY2409021

Description: Administered orally

Intervention Type: Drug

Intervention Name: Placebo

Description: Administered orally

Intervention Type: Drug

Intervention Name: Glucagon

Description: Administered via intramuscular injection

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
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
Location
Facility: 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.
Location Countries

Germany

Verification Date

March 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 100 mg LY2409021

Type: Experimental

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.

Label: 300 mg LY2409021

Type: Experimental

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.

Label: Placebo

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov