A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

Healthy Volunteers Clinical Trial

Official title:

Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654380
• Other study ID #: 12157
• Secondary ID: I2R-MC-BIAV
• Status: Completed
• Phase: Phase 1
• Start date: July 2012
• Est. completion date: October 2013

Study information

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

Clinical Trial Summary

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

All Participants

• Are healthy males or participants with T1DM

• Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)

Healthy Participants ONLY

• Are overtly healthy, as determined by medical history and physical examination

• Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening

Participants with T1DM ONLY

• Have a diagnosis of T1DM for at least 1 year based on medical history

• Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)

• Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening

• Have had no episodes of severe hypoglycemia in the past 6 months

Exclusion Criteria:

All Participants

• Have a hemoglobin level <12.0 grams/deciliter (g/dL)

• Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study

Healthy Participants ONLY

• Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).

Participants with T1DM ONLY

• Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing

• Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing

• Require a total daily insulin dose exceeding 100 units (U)

• Have fasting triglycerides >400 mg/dL

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Healthy Volunteers

Intervention

Drug:
• LY2605541
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).

Other:
• Insulin glargine
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Locations

Country	Name	City	State
United States	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.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part B: Glucodynamics: Endogenous Glucose Output	The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100.; The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.	Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Primary	Part B: Glycodynamics: Glucose Disposal	The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR.; The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.	Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Primary	Part B: Glycodynamics: Maximum Rate of Glucose Disposal	The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.	Baseline, up to 10 hours (duration of the euglycemic glucose clamp)