Type 2 Diabetes MellitusPhase 3NCT03952143
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 41 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LY900014, Insulin Lispro and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 27 May 2019to 20 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
China34 sites
Beijing Pinggu District Hospital
Beijing, Cn-11, 101200
Beijing Peking Union Medical College Hospital
Beijing, 100730
Cangzhou People's Hospital
Cangzhou, Cn-13, 061000
China-Japan Union Hospital, CJUH.
Changchun, Jilin, 130033
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213003
Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, 424300
Chongqing General Hospital
Chongqing, Cn-50, 400014
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Cn-21, 116033
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Inner Mongolia People's Hospital
Hohhot, Cn-15, 010017
The Affiliated Jiangyin Hospital of Southeast University Medical College
Jiangyin, Cn-32, 214400
Jinan Central Hospital
Jinan, Shandong, 250013
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471003
The Third Hospital of Nanchang
Nanchang, Cn-36, 330009
Zhongda Hospital Southeast University
Nanjing, Cn-32, 210009
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Cn-32, 211100
The First Hospital of Nanjing
Nanjing, Jiangsu, 210012
Pingxiang People's Hospital
Pingxiang, 337000
The First Hospital of Qinhuangdao
Qinhuangdao Shi, Cn-13, 066000
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161006
Shanghai Putuo District Center Hospital
Shanghai, Cn-31, 200062
Shanghai 6th people's hospital
Shanghai, Cn-31
Shengjing Hospital of China Medical University
Shenyang, Cn-21, 110004
Siping Central People's Hospital
Siping, Jilin, 136000
Tianjin Medical University General Hospital
Tianjin, Cn-12, 300052
The Central Hospital of Wuhan
Wuhan, Cn-42
Wuhan Pu'ai Hospital
Wuhan, Hubei, 430000
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi
Xingtai People's Hospital
Xingtai, Hebei, 054031
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
Yichang Central People's Hospital
Yichang, Hubei, 443003
The First People's Hospital of Yueyang
Yueyang, Cn-43, 414000
Affiliated Hospital of Jiangsu University
Zhenjiang, Cn-32, 212000
Mexico4 sites
Unidad de patologia Clinica
Guadalajara, Jalisco, 44650
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., 64460
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Mx-nle, 66465
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, 45116
Argentina3 sites
Centro Médico Viamonte
Buenos Aires, AR-C, C1120AAC
Centro de Investigaciones Metabólicas (CINME)
CABA, Buenos Aires, C1056ABJ
Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC
Córdoba, X5008HHW
About this study
Official title: 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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY900014Drug
Also called Ultra-Rapid Lispro
Administered SC
Insulin LisproDrug
Also called LY275585, Humalog
Administered SC
Insulin GlargineDrug
Administered SC
Insulin DegludecDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY900014 | Experimental | 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. Receives: Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec |
| Insulin Lispro | Active comparator | 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. Receives: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
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).
Measured: Baseline, Week 26
Secondary outcomes (8)
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
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).
Measured: Week 26
2-hour PPG Excursion During MMTT
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).
Measured: Week 26
Rate of Severe Hypoglycemia
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.
Measured: Baseline through Week 26
Rate of Documented Symptomatic Postmeal Hypoglycemia
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
Measured: Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
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)
Measured: Baseline, Week 26
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
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).
Measured: Baseline, Week 26
Change From Baseline in Insulin Dose
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)
Measured: Baseline, Week 26
Percentage of Participants With HbA1c <7% and ≤6.5%
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.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start27 May 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952143
- Sponsor's protocol ID
- 16830
- Other IDs
- I8B-FH-ITSE
- Status last verified
- Jan 2022
- First submitted
- 14 May 2019
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03952143
- Acronym / sponsor ID
- 16830
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 May 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 8 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY900014 | Experimental | Drug: LY900014, Drug: Insulin Glargine, Drug: Insulin DegludecParticipants 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. |
| Insulin Lispro | Active comparator | Drug: Insulin Lispro, Drug: Insulin Glargine, Drug: Insulin DegludecParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY900014Also: Ultra-Rapid LisproAdministered SC | Drug | LY900014 |
| Insulin LisproAlso: LY275585, HumalogAdministered SC | Drug | Insulin Lispro |
| Insulin GlargineAdministered SC | Drug | Insulin Lispro, LY900014 |
| Insulin DegludecAdministered SC | Drug | Insulin Lispro, LY900014 |
Primary outcome
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).
8 secondary outcomes
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
Time frame: Week 26
2-hour PPG Excursion During MMTT
Time frame: Week 26
Rate of Severe Hypoglycemia
Time frame: Baseline through Week 26
Rate of Documented Symptomatic Postmeal Hypoglycemia
Time frame: Baseline through Week 26
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
Time frame: Baseline, Week 26
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
Time frame: Baseline, Week 26
Change From Baseline in Insulin Dose
Time frame: Baseline, Week 26
Percentage of Participants With HbA1c <7% and ≤6.5%
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of Compared to Insulin Lispro (Humalog) in Adults With Type 2 DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY900014, Insulin Lispro and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 41 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China, Mexico, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.