Study of LY2409021 in Participants With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640834
• Other study ID #: 14576
• Secondary ID: I1R-MC-GLBR2011-
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: March 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• LY2409021
Administered orally
• Placebo
Administered orally
• Glucagon
Administered via intramuscular injection

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Day 1), Day 2
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021		Predose (Day 2) through 120 hours postdose (Day 7)
Secondary	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.	Predose (Day 2) through 120 hours postdose (Day 7)
Secondary	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.	Baseline (Day 1), Day 3 up to Day 6
Secondary	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.	Baseline (Day 1), Day 3 up to Day 6
Secondary	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.	Day 3
Secondary	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.	Day 3