A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

January 11, 2022 updated by: Eli Lilly and Company

A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
628

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5008HHW
        • Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
    • Ar-c
      • Buenos Aires, Ar-c, Argentina, C1120AAC
        • Centro Medico Viamonte
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1056ABJ
        • Centro de Investigaciones Metabolicas (CINME)
  • China
      • Beijing, China, 100730
        • Beijing Peking Union Medical College Hospital
      • Pingxiang, China, 337000
        • Pingxiang People's Hospital
    • Cn-11
      • Beijing, Cn-11, China, 101200
        • Beijing Pinggu District Hospital
    • Cn-12
      • Tianjin, Cn-12, China, 300052
        • Tianjin Medical University General Hospital
    • Cn-13
      • Cangzhou, Cn-13, China, 061000
        • Cangzhou People's Hospital
      • Qinhuangdao Shi, Cn-13, China, 066000
        • The First Hospital of Qinhuangdao
    • Cn-15
      • Hohhot, Cn-15, China, 010017
        • Inner Mongolia People's Hospital
    • Cn-21
      • Dalian, Cn-21, China, 116033
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
      • Shenyang, Cn-21, China, 110004
        • Shengjing Hospital of China Medical University
    • Cn-31
      • Shanghai, Cn-31, China, 200062
        • Shanghai Putuo District Center Hospital
      • Shanghai, Cn-31, China
        • Shanghai 6th People's Hospital
    • Cn-32
      • Jiangyin, Cn-32, China, 214400
        • The Affiliated Jiangyin Hospital of Southeast University Medical College
      • Nanjing, Cn-32, China, 210009
        • Zhongda Hospital Southeast University
      • Nanjing, Cn-32, China, 211100
        • Nanjing Medical University - Nanjing Jiangning Hospital
      • Zhenjiang, Cn-32, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Cn-36
      • Nanchang, Cn-36, China, 330009
        • The Third Hospital of Nanchang
    • Cn-42
      • Wuhan, Cn-42, China
        • The Central Hospital of Wuhan
    • Cn-43
      • Yueyang, Cn-43, China, 414000
        • The First People's Hospital of Yueyang
    • Cn-50
      • Chongqing, Cn-50, China, 400014
        • Chongqing General Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
    • Hebei
      • Xingtai, Hebei, China, 054031
        • Xingtai People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Qiqihar, Heilongjiang, China, 161006
        • The First Hospital of Qiqihar
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Wuhan Pu'ai Hospital
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
    • Hunan
      • Chenzhou, Hunan, China, 424300
        • Chenzhou No.1 people's Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital
      • Nanjing, Jiangsu, China, 210012
        • The First Hospital of Nanjing
    • Jilin
      • Changchun, Jilin, China, 130033
        • China-Japan Union Hospital, CJUH.
      • Siping, Jilin, China, 136000
        • Siping Central People's Hospital
    • Qinghai
      • Xining, Qinghai, China, 810001
        • Qinghai University Affiliated Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanxi
      • XI 'an, Shanxi, China
        • The First Affiliated Hospital of Xi'an Medical University
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Unidad de patologia Clinica
      • Zapopan, Jalisco, Mexico, 45116
        • Centro de Inv. Medica de Occidente, SC
    • Mx-nle
      • San Nicolás de los Garza, Mx-nle, Mexico, 66465
        • Unidad Médica para la Salud Integral
    • N.l.
      • Monterrey, N.l., Mexico, 64460
        • Hospital Universitario Dr. Jose Eleuterio González

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.
  • Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.
  • Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).
  • Participants must have a HbA1c ≥7.0% and ≤11.0%.
  • Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

Exclusion Criteria:

  • Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.
  • Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.
  • Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
  • Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY900014
Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
Drug: LY900014
Administered SC
Other Names:
  • Ultra-Rapid Lispro
Drug: Insulin Glargine
Administered SC
Drug: Insulin Degludec
Administered SC
Active Comparator: Insulin Lispro
Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.
Drug: Insulin Glargine
Administered SC
Drug: Insulin Degludec
Administered SC
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).
Baseline, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
Time Frame: Week 26
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
Week 26
2-hour PPG Excursion During MMTT
Time Frame: Week 26
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
Week 26
Rate of Severe Hypoglycemia
Time Frame: Baseline through Week 26
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525.
Baseline through Week 26
Rate of Documented Symptomatic Postmeal Hypoglycemia
Time Frame: Baseline through Week 26
Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable
Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
Time Frame: Baseline, Week 26
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)
Baseline, Week 26
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Time Frame: Baseline, Week 26
SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares).
Baseline, Week 26
Change From Baseline in Insulin Dose
Time Frame: Baseline, Week 26
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares)
Baseline, Week 26
Percentage of Participants With HbA1c <7% and ≤6.5%
Time Frame: Week 26
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16830
  • I8B-FH-ITSE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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