Trial · NCT02688933
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
NCT02688933, Phase 4, Completed, Sanofi; results first posted 2018-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus. Trials, record NCT02688933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02688933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
- NCT number
- NCT02688933
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 638 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml), Mandated back ground therapy
- First posted
- 2016-02-23
- Last updated
- 2022-03-28
- Results first posted
- 2018-08-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM | During Week 15 and/or 16 | The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16). |
| Secondary | Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | Baseline up to Week 16 | Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF). |
| Secondary | Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | Baseline up to Week 16 | Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG \<=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF. |
| Secondary | Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16 | Baseline, during Week 15 and/or Week 16 | Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16). |
| Secondary | Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection | During Week 15 and/or Week 16 | Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16). |
| Secondary | Coefficient of Variation (CV%) in Mean CGM Glucose | During Week 15 and/or Week 16 | CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values. |
| Other | Change From Baseline in Daily Insulin Dose at Week 16 | Baseline, Week 16 | Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM | During Week 15 and/or 16 | Modified intent-to-treat (mITT) population that included all participants who were randomized and had a post-baseline CGM assessment and enough CGM data values to calculate the primary outcome measure, percent of time in range of 70-180 mg/dL during Week 15 (and/or Week 16). | percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | Baseline up to Week 16 | mITT population. | percentage of participants | NUMBER |
| SECONDARY | Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | Baseline up to Week 16 | mITT population. | events per participant-year | NUMBER |
| SECONDARY | Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16 | Baseline, during Week 15 and/or Week 16 | mITT population. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection | During Week 15 and/or Week 16 | mITT population | percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Coefficient of Variation (CV%) in Mean CGM Glucose | During Week 15 and/or Week 16 | mITT population. | percent of mean glucose level | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Daily Insulin Dose at Week 16 | Baseline, Week 16 | Safety population: all participants who took at least 1 dose of randomized treatment \& analyzed as-treated (as per treatment actually received) also to whom it was unclear whether they took study medication \& who received more than 1 study treatment during trial. Here, number analyzed: number of participants evaluable for each specified category. | International Units | MEAN |
| POST_HOC | Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16 | Baseline, during Week 15 and/or Week 16 | mITT population. Here, number analyzed signifies the number of participants evaluable for each specified category. | minutes | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM | HOE901-U300 | 55.40 | Standard Error 1.08 | percentage of time | |
| Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM | Lantus | 55.18 | Standard Error 1.10 | percentage of time | |
| Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | HOE901-U300 | Documented <=70mg/dL | 70.8 | percentage of participants | |
| Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | Lantus | Documented <=70mg/dL | 68.3 | percentage of participants | |
| Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | HOE901-U300 | Documented <54 mg/dL | 50.9 | percentage of participants | |
| Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia | Lantus | Documented <54 mg/dL | 54.1 | percentage of participants | |
| Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | HOE901-U300 | Documented <=70 mg/dL | 11.38 | events per participant-year | |
| Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | Lantus | Documented <=70 mg/dL | 11.39 | events per participant-year | |
| Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | HOE901-U300 | Documented <54 mg/dL | 4.99 | events per participant-year | |
| Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year | Lantus | Documented <54 mg/dL | 5.61 | events per participant-year |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HOE901-U300 | 320 | |
| Overall Study | STARTED | Lantus | 318 | |
| Overall Study | COMPLETED | HOE901-U300 | 291 | |
| Overall Study | COMPLETED | Lantus | 281 | |
| Overall Study | NOT COMPLETED | HOE901-U300 | 29 | |
| Overall Study | NOT COMPLETED | Lantus | 37 |
Source ClinicalTrials.gov
Adverse events60
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 | Nasopharyngitis | Infections and infestations | HOE901-U300 | 27 | 320 | |
| other | Nasopharyngitis | Infections and infestations | Lantus | 27 | 318 | |
| other | Upper respiratory tract infection | Infections and infestations | HOE901-U300 | 28 | 320 | |
| other | Upper respiratory tract infection | Infections and infestations | Lantus | 28 | 318 | |
| serious | Diabetic foot infection | Infections and infestations | HOE901-U300 | 0 | 320 | |
| serious | Diabetic foot infection | Infections and infestations | Lantus | 1 | 318 | |
| serious | Gangrene | Infections and infestations | HOE901-U300 | 0 | 320 | |
| serious | Gangrene | Infections and infestations | Lantus | 1 | 318 | |
| serious | Influenza | Infections and infestations | HOE901-U300 | 1 | 320 | |
| serious | Influenza | Infections and infestations | Lantus | 0 | 318 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HOE901-U300 | 0 | 320 |
| Total, all-cause mortality | Lantus | 0 | 318 |
| Total, other adverse events | HOE901-U300 | 54 | 320 |
| Total, other adverse events | Lantus | 54 | 318 |
| Total, serious adverse events | HOE901-U300 | 17 | 320 |
| Total, serious adverse events | Lantus | 14 | 318 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HOE901-U300 vs Lantus: deaths from any cause | Trial comparisons |
| HOE901-U300 vs Lantus: serious adverse events | 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/NCT02688933
GET https://conductscience.org/api/trials/v1/NCT02688933/results?page=2