Study of LY2409021 in Participants With Type 1 Diabetes

NCT01640834 | Completed Phase 1 Results

• 3 other identifiers: 14576I1R-MC-GLBR2011-006178-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1), Day 2

Secondary Outcomes (7)

• 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

Study Arms (3)

100 mg LY2409021

EXPERIMENTAL

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.

Drug: LY2409021; Drug: Placebo; Drug: Glucagon

300 mg LY2409021

EXPERIMENTAL

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.

Drug: LY2409021; Drug: Glucagon

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Glucagon

Interventions

LY2409021 DRUG

Administered orally

100 mg LY2409021; 300 mg LY2409021

Placebo DRUG

Administered orally

100 mg LY2409021; Placebo

Glucagon DRUG

Administered via intramuscular injection

100 mg LY2409021; 300 mg LY2409021; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

adomeglivant; Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 16, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-03

Locations

DE (1)