Trial · NCT01454284
A Study in Participants With Type I Diabetes Mellitus
NCT01454284, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Participants With Type I Diabetes Mellitus. Trials, record NCT01454284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01454284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Participants With Type I Diabetes Mellitus
- NCT number
- NCT01454284
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,114 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Glargine, LY2605541, Insulin Lispro
- First posted
- 2011-10-18
- Last updated
- 2018-04-17
- Other registries' IDs
- eudract:2011-001253-82
- Results first posted
- 2018-04-17
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemoglobin A1c (HbA1c) | 52 weeks | HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, stratification factors (country, baseline low density lipoprotein cholesterol \[LDL-C\] \[\<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter \[mmol/L\]) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. |
| Secondary | Hemoglobin A1c (HbA1c) | 26 weeks | HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C \[\<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. |
| Secondary | Change From Baseline to 52 Weeks in HbA1c | Baseline, 52 weeks | HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C \[\<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. |
| Secondary | Total Hypoglycemia Events | Baseline through 26 weeks, Baseline through 52 weeks | Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. |
| Secondary | Percentage of Participants With Total Hypoglycemic Events | Baseline through 26 weeks, Baseline through 52 weeks | Hypoglycemic episodes are defined as events that are associated with the reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0% | up to 26 weeks, up to 52 weeks | The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. |
| Secondary | Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia | up to 26 weeks, up to 52 weeks | Hypoglycemic episodes are defined as events associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c \<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100. |
| Secondary | Nocturnal Hypoglycemia Rates | Baseline through 26 weeks, Baseline through 52 weeks | Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. |
| Secondary | Percentage of Participants With Nocturnal Hypoglycemic Events | Baseline through 26 weeks, Baseline through 52 weeks | Hypoglycemic episodes are defined as events associated with the reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. |
| Secondary | Change in Body Weight | Baseline, 26 weeks, 52 weeks | LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, baseline LDL-C \[\<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)\], baseline prior basal insulin therapy \[insulin glargine/detemir/other\]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hemoglobin A1c (HbA1c) | 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Hemoglobin A1c (HbA1c) | 26 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 52 Weeks in HbA1c | Baseline, 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Total Hypoglycemia Events | Baseline through 26 weeks, Baseline through 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline. | episodes/participant/30 days | MEAN |
| SECONDARY | Percentage of Participants With Total Hypoglycemic Events | Baseline through 26 weeks, Baseline through 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0% | up to 26 weeks, up to 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia | up to 26 weeks, up to 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method, using only post-baseline data. | percentage of participants | NUMBER |
| SECONDARY | Nocturnal Hypoglycemia Rates | Baseline through 26 weeks, Baseline through 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline. | events/participant/30 days | MEAN |
| SECONDARY | Percentage of Participants With Nocturnal Hypoglycemic Events | Baseline through 26 weeks, Baseline through 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline. | percentage of participants | NUMBER |
| SECONDARY | Change in Body Weight | Baseline, 26 weeks, 52 weeks | Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline. | kilograms (kg) | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hemoglobin A1c (HbA1c) | LY2605541 + Insulin Lispro | 7.38 | Standard Error 0.03 | percentage of HbA1c | |
| Hemoglobin A1c (HbA1c) | Insulin Glargine + Insulin Lispro | 7.61 | Standard Error 0.04 | percentage of HbA1c | |
| Hemoglobin A1c (HbA1c) | LY2605541 + Insulin Lispro | 7.09 | Standard Error 0.03 | percentage of HbA1c | |
| Hemoglobin A1c (HbA1c) | Insulin Glargine + Insulin Lispro | 7.42 | Standard Error 0.03 | percentage of HbA1c | |
| Change From Baseline to 52 Weeks in HbA1c | LY2605541 + Insulin Lispro | -0.46 | Standard Error 0.03 | percentage of HbA1c | |
| Change From Baseline to 52 Weeks in HbA1c | Insulin Glargine + Insulin Lispro | -0.24 | Standard Error 0.04 | percentage of HbA1c | |
| Total Hypoglycemia Events | LY2605541 + Insulin Lispro | Weeks 0-26 | 16.83 | Standard Error 0.36 | episodes/participant/30 days |
| Total Hypoglycemia Events | Insulin Glargine + Insulin Lispro | Weeks 0-26 | 14.66 | Standard Error 0.36 | episodes/participant/30 days |
| Total Hypoglycemia Events | LY2605541 + Insulin Lispro | Weeks 0-52 | 15.34 | Standard Error 0.32 | episodes/participant/30 days |
| Total Hypoglycemia Events | Insulin Glargine + Insulin Lispro | Weeks 0-52 | 13.88 | Standard Error 0.35 | episodes/participant/30 days |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2605541 + Insulin Lispro | 664 | |
| Overall Study | STARTED | Insulin Glargine + Insulin Lispro | 450 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2605541 + Insulin Lispro | 663 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Insulin Glargine + Insulin Lispro | 449 | |
| Overall Study | COMPLETED | LY2605541 + Insulin Lispro | 548 | |
| Overall Study | COMPLETED | Insulin Glargine + Insulin Lispro | 377 | |
| Overall Study | NOT COMPLETED | LY2605541 + Insulin Lispro | 116 | |
| Overall Study | NOT COMPLETED | Insulin Glargine + Insulin Lispro | 73 |
Source ClinicalTrials.gov
Adverse events236
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 | Diarrhoea | Gastrointestinal disorders | LY2605541 + Insulin Lispro | 14 | 663 | 16 |
| other | Diarrhoea | Gastrointestinal disorders | Insulin Glargine + Insulin Lispro | 16 | 449 | 17 |
| other | Nausea | Gastrointestinal disorders | LY2605541 + Insulin Lispro | 21 | 663 | 27 |
| other | Nausea | Gastrointestinal disorders | Insulin Glargine + Insulin Lispro | 17 | 449 | 18 |
| other | Vomiting | Gastrointestinal disorders | LY2605541 + Insulin Lispro | 20 | 663 | 20 |
| other | Vomiting | Gastrointestinal disorders | Insulin Glargine + Insulin Lispro | 16 | 449 | 21 |
| other | Injection site hypertrophy | General disorders | LY2605541 + Insulin Lispro | 16 | 663 | 20 |
| other | Injection site hypertrophy | General disorders | Insulin Glargine + Insulin Lispro | 0 | 449 | 0 |
| other | Bronchitis | Infections and infestations | LY2605541 + Insulin Lispro | 16 | 663 | 17 |
| other | Bronchitis | Infections and infestations | Insulin Glargine + Insulin Lispro | 12 | 449 | 14 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2605541 + Insulin Lispro | ||
| Total, all-cause mortality | Insulin Glargine + Insulin Lispro | ||
| Total, other adverse events | LY2605541 + Insulin Lispro | 502 | 663 |
| Total, other adverse events | Insulin Glargine + Insulin Lispro | 305 | 449 |
| Total, serious adverse events | LY2605541 + Insulin Lispro | 117 | 663 |
| Total, serious adverse events | Insulin Glargine + Insulin Lispro | 92 | 449 |
Source ClinicalTrials.gov
Papers4
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2605541 + Insulin Lispro vs Insulin Glargine + Insulin Lispro: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01454284
GET https://conductscience.org/api/trials/v1/NCT01454284/registered?page=2