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NCT Number: NCT01925989

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2605541

Biological

Administered SQ

Insulin Glargine

Biological

Administered SQ

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Lipid Oxidation in T1DM and Healthy Participants

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

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

  2. Basal Metabolic Rate (BMR) for T1DM

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

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

  3. Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants

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

    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.

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

    Time frame: Day 5, every minute through 23 hour period

    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.

  5. Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM

    Time frame: Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Evaluation of the Effects of Insulin Peglispro (LY2605541) on Respiratory Quotient During Sleep and Response to Hyperinsulinemia Compared With That of Insulin Glargine in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2013
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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