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

Phase 1CompletedNCT01925989

Eli Lilly and Company27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

LY2605541BIOLOGICAL

Administered SQ

Insulin GlargineBIOLOGICAL

Administered SQ

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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

Locations (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, United States

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

Lipid Oxidation in T1DM and Healthy Participants

Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.

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

Basal Metabolic Rate (BMR) for T1DM

BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.

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

Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants

The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations 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. The overnight period was averaged based on all 1-minutes interval measurements for the duration of the overnight period.

Time frame: Day 5, overnight period (0000 to 0600 hours)

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

The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations 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.It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole data based on all 1-minutes interval measurements for the duration of the overnight period.

Data from ClinicalTrials.gov

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