A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

NCT01925989 | Completed Phase 1 Results

• 2 other identifiers: 14872I2R-MC-BIDO
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each period, participants will receive once daily injections of stable dose LY2605541 or insulin glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats and sugars. Participants will continue to use meal time insulin throughout the study. Healthy participants will also enroll in the study. They will not receive any study medication.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)

  Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC).

  Day 30 post dose, overnight period (0000 to 0600 hours)

Secondary Outcomes (5)

• Lipid Oxidation in T1DM and Healthy Participants

  Day 30 post dose, overnight period (0000 to 0600 hours)

• Basal Metabolic Rate (BMR) for T1DM

  Day 30 post dose, overnight period (0000 to 0600 hours)

• Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants

  Day 5, overnight period (0000 to 0600 hours)

• Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants

  Day 5, every minute through 23 hour period

• Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM

  Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours

Study Arms (3)

Insulin Peglispro/Insulin Glargine

EXPERIMENTAL

Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin.

Biological: LY2605541

Insulin Glargine/Insulin Peglispro

ACTIVE COMPARATOR

Insulin glargine administered to participants with T1DM SQ QD for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen. Participants continue to use mealtime insulin. Insulin peglispro (LY2605541) administered to participants with T1DM subcutaneously (SQ) once daily (QD) for 28 to 35 days in one of two treatment periods. Dose is based on participant's prestudy basal insulin dosing regimen.

Biological: Insulin Glargine

Control

NO INTERVENTION

Control Arm. Untreated healthy participants.

Interventions

LY2605541 BIOLOGICAL

Administered SQ

Insulin Peglispro/Insulin Glargine

Insulin Glargine BIOLOGICAL

Administered SQ

Insulin Glargine/Insulin Peglispro

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 Diabetics:
• \- T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%
• All Participants:
• Otherwise fit and healthy
• Non smoker

You may not qualify if:

• Type 1 Diabetics:
• Taking medication or supplements other than insulin to control diabetes
• Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
• All Participants:
• \- Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, 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

Limitations and Caveats

One participant in the Insulin Glargine/Insulin Peglispro arm withdrew consent prior to being dosed with study drug and is included in the Adverse Event (AE) section.

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2018-10

Locations

US (1)