Type 2 DiabetesPhase 3NCT04605991
A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)
A Phase 3 study testing LY900014 and Insulin Glargine in people with Type 2 Diabetes, run by Eli Lilly and Company at 32 sites in 2 countries.
Trial summary
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- LY900014 and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 4 Nov 2020to 4 Feb 2022
- 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 diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
- Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:
- Basal insulin glargine U-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals.
- Participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening.
- Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
- Metformin
Show all 12Show fewer
- Dipeptidyl peptidase-4 (DPP-4) inhibitor
- sodium glucose cotransporter 2 (SGLT2) inhibitor
- oral glucagon-like peptide 1 (GLP-1) agonist
- Doses of OAMs are required to have been stable for at least 90 days prior to screening.
- Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
- Have an HbA1c value ≥7.5% and ≤10% according to the central laboratory at screening.
Who cannot join
- Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
- Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
- Have hypoglycemia unawareness as judged by the investigator.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States30 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78749
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229
Burke Internal Medicine and Research
Burke, Virginia, 22015
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Dallas Diabetes Research Center
Dallas, Texas, 75230
AMCR Institute
Escondido, California, 92025
Valley Endocrine, Fresno
Fresno, California, 93720
CMR of Greater New Haven
Hamden, Connecticut, 06517
Encore Medical Research
Hollywood, Florida, 33021
Biopharma Informatic, LLC
Houston, Texas, 77043
Endocrine Ips, Pllc
Houston, Texas, 77079
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Palm Research Center Tenaya
Las Vegas, Nevada, 89128
Palm Research Center Tenaya
Las Vegas, Nevada, 89148
East Coast Institute for Research at The Jones Center
Macon, Georgia, 31210
Manassas Clinical Research Center
Manassas, Virginia, 20110
Cataret Medical Group
Morehead City, North Carolina, 28557
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652
Research NYC, Inc
New York, New York, 10016
Intend Research, LLC
Norman, Oklahoma, 73069
Rainier Clinical Research Center
Renton, Washington, 98057
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711
Suny Health Science Center at Syracuse
Syracuse, New York, 13210
University Clinical Investigators, Inc.
Tustin, California, 92780
Coastal Metabolic Research Centre
Ventura, California, 93003
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
Puerto Rico2 sites
Advanced Clinical Research, LLC
Bayamón, 00961
Manati Center for Clinical Research Inc
Manati, PR, 00674
About this study
Official title: A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
- Conditions
- Type 2 Diabetes
- Being tested
- LY900014, Insulin Glargine
- 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
Administered SC
Insulin GlargineDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY900014 | Experimental | LY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study. Receives: Drug: LY900014; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
Measured: Baseline, Week 12
Secondary outcomes (11)
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12
iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from Glucose measures taken every 15 minutes from 0 to 1 hour after meal using CGM sensor (i.e., 0, 15, 30, 45, 60 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.
Measured: Baseline, Week 12
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12
iAUC reflects the metabolic control and is calculated using the standard trapezoidal rule from glucose measures taken every 15 minutes from 0 to 2 hours after meal using CGM sensor (i.e., 0, 15, 30, 45, 60, 75, 90, 105, 120 minutes after meal). LS mean was determined by ANCOVA (analysis of covariance) with Baseline as covariate.
Measured: Baseline, Week 12
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Measured: Week 12
Change From Baseline in Daily Insulin Dose at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12
LS mean was determined by MMRM model with Baseline + Time as variables.
Measured: Baseline, Week 12
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12
The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for subjects taking insulin under 5 domains: Inconvenience of Regimen [IR - 5 items], Lifestyle Flexibility [LF - 3 items], Glycemic Control [GC - 3 items], Hypoglycemic Control [HC - 5 items], Insulin Delivery Device [IDD - 6 items]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. Data presented are for Glycemic Control Domain Scores transformed on a 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better glycemic control. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as a covariate.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start4 Nov 2020
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 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
- NCT04605991
- Sponsor's protocol ID
- 17428
- Other IDs
- I8B-MC-ITSW
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2020
- Last updated
- 3 Mar 2023
- 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.
Publications
Bailey TS, Bode BW, Wang Q, Knights AW, Chang AM. Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range. Diabetes Ther. 2023 May;14(5):883-897. doi: 10.1007/s13300-023-01400-w. Epub 2023 Apr 7.
PubMed 37029268
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04605991
- Acronym / sponsor ID
- 17428
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 3 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin LY900014 in combination with long-acting insulin glargine. Participants will use continuous glucose monitoring (CGM) (Freestyle Libre 14-day system) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY900014 | Experimental | Drug: LY900014, Drug: Insulin GlargineLY900014 (100 units/milliliter (U/mL)) is a mealtime insulin administered subcutaneously (SC) 0-2 minutes prior to each meal in combination with insulin glargine (100 U/mL) SC as long-acting insulin. Mealtime (bolus) and long-acting (basal) insulin doses were titrated to achieve glucose targets during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants diagnosed (clinically) with type 2 diabetes mellitus (T2D) for at least 1 year prior to screening.
- Have been treated with basal-bolus multiple daily injection (MDI) therapy for at least 90 days prior to screening including:
- Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) for T2D in accordance with local regulations:
- Doses of OAMs are required to have been stable for at least 90 days prior to screening.
- Participants may be treated with injectable GLP-1 receptor agonist for T2D in accordance with local regulations. The GLP-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening.
Key exclusion criteria (4 listed)
- Have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults.
- Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening.
- Have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening.
- Have hypoglycemia unawareness as judged by the investigator.
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 |
|---|---|---|
| LY900014Administered SC | Drug | LY900014 |
| Insulin GlargineAdministered SC | Drug | LY900014 |
Primary outcome
Change From Baseline in Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12
Time frame: Baseline, Week 12
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Time as variables.
11 secondary outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values Between 70-180 mg/dL (3.9-10.0 mmol/L) (Both Inclusive) During the 24-hour Period at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values <54 mg/dL (<3.0 mmol/L) During Daytime and 24-hour Periods at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Values >180 mg/dL (>10.0 mmol/L) During Daytime and 24-hour Period at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Percentage of Time With CGM Sensor Glucose Value >250 mg/dL (>13.9 mmol/L) During Daytime and 24-hour Period at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-1 Hour at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Incremental Area Under the Glucose Curve (iAUC) 0-2 Hour at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With HbA1c <7% and ≤6.5%
Time frame: Week 12
Change From Baseline in Daily Insulin Dose at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Bolus/Total Insulin Dose Percentage at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) - Glycemic Control Domain Score at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37029268Bailey TS, Bode BW, Wang Q, Knights AW, Chang AM. Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range. Diabetes Ther. 2023 May;14(5):883-897. doi: 10.1007/s13300-023-01400-w. Epub 2023 Apr 7.
- A Study of Mealtime Insulin LY900014 in Participants with Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range)Link 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.
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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
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LY900014 and Insulin Glargine in people with Type 2 Diabetes, run by Eli Lilly and Company at 32 sites in 2 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 12 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico. 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 3 Mar 2023). 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 Percentage of Time With Continuous Glucose Monitoring (CGM) Sensor Glucose Values Between 70-180 Milligrams/Deciliter (mg/dL) (3.9-10.0 Millimoles/Liter [mmol/L]) (Both Inclusive) During Daytime Period at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04605991, which also lists 1 linked publication.
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 3 Mar 2023.