Study of LY2409021 in Participants With Type 1 Diabetes

NCT ID: NCT01640834

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-09-30

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

100 mg LY2409021

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.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Glucagon

Intervention Type: DRUG

Administered via intramuscular injection

300 mg LY2409021

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.

Group Type: EXPERIMENTAL

LY2409021

Intervention Type: DRUG

Administered orally

Glucagon

Intervention Type: DRUG

Administered via intramuscular injection

Placebo

Placebo: 3 capsules administered as a single oral dose on Day 2.

Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally

Glucagon

Intervention Type: DRUG

Administered via intramuscular injection

Interventions

LY2409021

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Glucagon

Administered via intramuscular injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

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.

Neuss, , Germany

Countries

Germany

Other Identifiers

I1R-MC-GLBR

Identifier Type: OTHER

Identifier Source: secondary_id

2011-006178-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14576

Identifier Type: -

Identifier Source: org_study_id