Trial · NCT03214367
A Study of LY900014 in Participants With Type 1 Diabetes
NCT03214367, Phase 3, Completed, Eli Lilly and Company; results first posted 2020-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY900014 in Participants With Type 1 Diabetes. Trials, record NCT03214367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03214367
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY900014 in Participants With Type 1 Diabetes
- NCT number
- NCT03214367
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,392 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec
- First posted
- 2017-07-11
- Last updated
- 2020-05-01
- Other registries' IDs
- eudract:2015-005356-99
- Results first posted
- 2020-05-01
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | 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 strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | Baseline, 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. 1-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | Baseline, 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. 2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, prandial insulin dosing plan, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug. |
| Secondary | Rate of Severe Hypoglycemia at Week 26 | Baseline through Week 26 | Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. 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 a treatment group \*36525. |
| Secondary | Rate of Documented Symptomatic Hypoglycemia at Week 26 | Baseline through Week 26 | Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \<54 mg/dL \[3.0 millimole per liter (mmol/L)\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable. |
| Secondary | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 | 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) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26 | 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) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in Insulin Dose at Week 26 | Baseline, Week 26 | LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26 | Baseline, Week 26 | ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug. |
| Secondary | Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 | Baseline, Week 26 | ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS Mean was calculated using the analysis of covariance (ANCOVA) with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug. The analysis included data prior to permanent discontinuation of study drug. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | milligrams per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Severe Hypoglycemia at Week 26 | Baseline through Week 26 | All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Events per 100 participant years | NUMBER |
| SECONDARY | Rate of Documented Symptomatic Hypoglycemia at Week 26 | Baseline through Week 26 | All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Events per participant per year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | milligram per liter (mg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Dose at Week 26 | Baseline, Week 26 | All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units (U)/day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26 | Baseline, Week 26 | All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 | Baseline, Week 26 | All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the LOCF method to the post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | LY900014 | -0.13 | Standard Error 0.031 | Percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | LY900014 Postmeal | 0.08 | Standard Error 0.035 | Percentage of HbA1c | |
| Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26 | Insulin Lispro (Humalog) | -0.05 | Standard Error 0.031 | Percentage of HbA1c | |
| Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | LY900014 | -28.6 | Standard Error 3.33 | milligrams per deciliter (mg/dL) | |
| Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | LY900014 Postmeal | 12.5 | Standard Error 3.74 | milligrams per deciliter (mg/dL) | |
| Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 26 | Insulin Lispro (Humalog) | -0.7 | Standard Error 3.34 | milligrams per deciliter (mg/dL) | |
| Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | LY900014 | -34.7 | Standard Error 4.50 | mg/dL | |
| Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | LY900014 Postmeal | -10.2 | Standard Error 5.04 | mg/dL | |
| Change From Baseline in 2-hour PPG Excursion During MMTT Efficacy Estimand at Week 26 | Insulin Lispro (Humalog) | -3.5 | Standard Error 4.51 | mg/dL | |
| Rate of Severe Hypoglycemia at Week 26 | LY900014 | 16.50 | Events per 100 participant years |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-in Period | STARTED | Insulin Lispro (Humalog) Lead-in | 1,316 | |
| Lead-in Period | STARTED | Insulin Lispro (Humalog) | 0 | |
| Lead-in Period | STARTED | LY900014 | 0 | |
| Lead-in Period | STARTED | LY900014 Postmeal | 0 | |
| Lead-in Period | STARTED | Insulin Lispro (Humalog) Lead-In Maximum Extended Enrollment | 76 | |
| Lead-in Period | STARTED | Insulin Lispro (Humalog)- Maximum Extended Enrollment (MEE) | 0 | |
| Lead-in Period | STARTED | LY900014-MEE | 0 | |
| Lead-in Period | STARTED | LY900014 Postmeal-MEE | 0 | |
| Lead-in Period | COMPLETED | Insulin Lispro (Humalog) Lead-in | 1,222 | |
| Lead-in Period | COMPLETED | Insulin Lispro (Humalog) | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events864
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Insulin Lispro (Humalog) Lead-in | 4 | 1,316 | 4 |
| other | Pyrexia | General disorders | Insulin Lispro (Humalog) | 2 | 442 | 2 |
| other | Pyrexia | General disorders | LY900014 | 6 | 451 | 7 |
| other | Pyrexia | General disorders | LY900014 Postmeal | 8 | 329 | 8 |
| other | Pyrexia | General disorders | Insulin Lispro (Humalog) Lead-in-MEE | 2 | 76 | 2 |
| other | Pyrexia | General disorders | Insulin Lispro (Humalog)-MEE | 4 | 31 | 4 |
| other | Pyrexia | General disorders | LY900014-MEE | 1 | 21 | 1 |
| other | Pyrexia | General disorders | LY900014 Postmeal-MEE | 0 | 22 | 0 |
| other | Cellulitis | Infections and infestations | Insulin Lispro (Humalog) Lead-in | 1 | 1,316 | 1 |
| other | Cellulitis | Infections and infestations | Insulin Lispro (Humalog) | 2 | 442 | 2 |
1 to 10 of 864Source ClinicalTrials.gov
See all 864 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin Lispro (Humalog) Lead-in | 0 | 1,316 |
| Total, all-cause mortality | Insulin Lispro (Humalog) | 1 | 442 |
| Total, all-cause mortality | LY900014 | 1 | 451 |
| Total, all-cause mortality | LY900014 Postmeal | 1 | 329 |
| Total, all-cause mortality | Insulin Lispro (Humalog) Lead-in-MEE | 0 | 76 |
| Total, all-cause mortality | Insulin Lispro (Humalog)-MEE | 0 | 31 |
| Total, all-cause mortality | LY900014-MEE | 0 | 21 |
| Total, all-cause mortality | LY900014 Postmeal-MEE | 0 | 22 |
| Total, other adverse events | Insulin Lispro (Humalog) Lead-in | 131 | 1,316 |
| Total, other adverse events | Insulin Lispro (Humalog) | 147 | 442 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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