A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

NCT01654380 | Completed Phase 1 Results

• 2 other identifiers: 12157I2R-MC-BIAV
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (6)

Part A, Cohort A; LY2605541

EXPERIMENTAL

Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period

Drug: LY2605541

Part A, Cohort A; Insulin Glargine

ACTIVE COMPARATOR

Healthy participants received insulin glargine (30 milliunits/meter squared/minute \[mU/m\^2/min\]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period

Other: Insulin glargine

Part A, Cohort B; LY2605541

EXPERIMENTAL

Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period.

Drug: LY2605541

Part A, Cohort B; Insulin Glargine

ACTIVE COMPARATOR

Healthy participants received insulin glargine (60 mU/m\^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.

Other: Insulin glargine

Part B; LY2605541

EXPERIMENTAL

Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.

Drug: LY2605541

Part B; Insulin Glargine

ACTIVE COMPARATOR

Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m\^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.

Other: Insulin glargine

Interventions

LY2605541 DRUG

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

Part A, Cohort A; LY2605541; Part A, Cohort B; LY2605541; Part B; LY2605541

Insulin glargine OTHER

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

Part A, Cohort A; Insulin Glargine; Part A, Cohort B; Insulin Glargine; Part B; Insulin Glargine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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.

San Diego, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

LY2605541; Insulin Glargine

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)

Insulin, Long-Acting; Insulins; 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: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 8, 2019
• Results First Posted: March 8, 2019

Record last verified: 2018-11

Locations

US (1)