Clinical trial NCT01640834: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
timeFrame: Baseline (Day 1), Day 2
Secondary outcomes:
measure: Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
timeFrame: Baseline (Day 1), Day 2
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
timeFrame: Predose (Day 2) through 120 hours postdose (Day 7)
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
timeFrame: Predose (Day 2) through 120 hours postdose (Day 7)
measure: Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
timeFrame: Baseline (Day 1), Day 3 up to Day 6
measure: Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
timeFrame: Baseline (Day 1), Day 3 up to Day 6
measure: Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
timeFrame: Day 3
measure: Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
timeFrame: Day 3
Other outcomes:
Locations:
city: Neuss
country: Germany
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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: