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Completed

NCT Number: NCT04585776

A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes

In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.

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Key information

Conditions

Type 1 Diabetes 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atlanta Diabetes Associates, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
  • Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
  • Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
  • Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening

Exclusion criteria

  • Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
  • Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
  • Participants must not be taking certain diabetes medications that are not allowed for study participation

Treatment and study plan

LY900014

Drug

Administered SC

insulin degludec

Drug

Administered SC

Primary outcomes

  1. Percentage of Time With Sensor Glucose Values Between 70 and 180 Milligrams Per Deciliter (mg/dL) With Continuous Glucose Monitoring (CGM)

    Time frame: Day 46

    Percentage of Time with Sensor Glucose Values Between 70 and 180 mg/dL (both inclusive) with CGM.

Secondary outcomes

  1. Insulin to Carbohydrate Ratio (ICR)

    Time frame: Day 46

    ICR was evaluated to estimate how many carbohydrates will be covered by one unit of insulin.

  2. Ratio of Prandial Dose to Total Daily Dose (TDD) of Insulin

    Time frame: Day 46

    Prandial:TDD ratio

  3. Product of Insulin to Carbohydrate Ratio and Total Daily Dose (ICR×TDD)

    Time frame: Day 46

    ICR×TDD is determined to evaluate the relationship between insulin to carbohydrate ratio (g/U) and the total daily insulin dose (U/day).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Exploratory Study Assessing Time in Target Glucose Range Using a New Titration Scheme of LY900014 and Insulin Degludec in Patients With Type 1 Diabetes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jun 3, 2022

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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