Trial · NCT02735044
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
NCT02735044, Phase 3, Completed, Sanofi; results first posted 2019-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus. Trials, record NCT02735044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02735044
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
- NCT number
- NCT02735044
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 463 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Insulin glargine,300 U/mL, Insulin glargine (100 units /mL), Background therapy
- First posted
- 2016-04-12
- Last updated
- 2022-03-25
- Other registries' IDs
- eudract:2015-002084-42
- Results first posted
- 2019-06-19
- Limitations and caveats
- None reported
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HbA1c to Month 6 | Baseline to Month 6 | Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 | Baseline to Month 6 | Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period. |
| Secondary | Percentage of Participants With HbA1c Values of <7.5% at Month 6 | Month 6 | Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years). |
| Secondary | Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | upto Month 6 | Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years). |
| Secondary | Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 | Month 6 | Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years). |
| Secondary | Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | upto Month 6 | Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years). |
| Secondary | Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6 | Baseline to Month 6 | 8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%), randomization strata of age at screening (\<12 years, \>=12 years) and the baseline 24-hour average 8-point profile SMPG. |
| Secondary | Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6 | Baseline, Month 6 | 8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (\<8.5%; \>=8.5%) and randomization strata of age at screening (\<12 years, \>=12 years). |
| Secondary | Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point | Baseline to Month 6 | 8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. |
| Secondary | Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12 | Month 12 | Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration \<=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration \<=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration \>70 mg/dL. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 HbA1c to Month 6 | Baseline to Month 6 | Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, regardless of whether the treatment kit was used, and was analyzed according to the allocated treatment group. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure. | Percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 | Baseline to Month 6 | Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c Values of <7.5% at Month 6 | Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | upto Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 | Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | upto Month 6 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6 | Baseline to Month 6 | Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6 | Baseline, Month 6 | Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure. | percentage of mean variability | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point | Baseline to Month 6 | Analysis was performed on ITT population. Here, 'number analyzed' = participants with available data for each specified category. | mmol/L | MEAN |
| SECONDARY | Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12 | Month 12 | Analysis was performed on the safety population which included all randomized participants who actually received who received at least 1 dose or part of a dose of IMP, and was analyzed according to treatment received. | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group48
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 HbA1c to Month 6 | HOE901-U300 | -0.399 | Standard Error 0.063 | Percentage of HbA1c | |
| Change From Baseline in HbA1c to Month 6 | Lantus | -0.402 | Standard Error 0.064 | Percentage of HbA1c | |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 | HOE901-U300 | -0.563 | Standard Error 0.372 | millimole per liter (mmol/L) | |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 | Lantus | -0.549 | Standard Error 0.372 | millimole per liter (mmol/L) | |
| Percentage of Participants With HbA1c Values of <7.5% at Month 6 | HOE901-U300 | 26.18 | percentage of participants | ||
| Percentage of Participants With HbA1c Values of <7.5% at Month 6 | Lantus | 23.48 | percentage of participants | ||
Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | HOE901-U300 | 4.29 | percentage of participants | ||
Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period | Lantus | 4.78 | percentage of participants | ||
| Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 | HOE901-U300 | 27.47 | percentage of participants | ||
| Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 | Lantus | 26.52 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HOE901-U300 | 233 | |
| Overall Study | STARTED | Lantus | 230 | |
| Overall Study | Treated | HOE901-U300 | 233 | |
| Overall Study | Treated | Lantus | 228 | |
| Overall Study | COMPLETED | HOE901-U300 | 217 | |
| Overall Study | COMPLETED | Lantus | 207 | |
| Overall Study | NOT COMPLETED | HOE901-U300 | 16 | |
| Overall Study | NOT COMPLETED | Lantus | 23 |
Source ClinicalTrials.gov
Adverse events88
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 | Vomiting | Gastrointestinal disorders | HOE901-U300 | 14 | 233 | 20 |
| other | Vomiting | Gastrointestinal disorders | Lantus | 9 | 228 | 10 |
| other | Gastroenteritis | Infections and infestations | HOE901-U300 | 12 | 233 | 14 |
| other | Gastroenteritis | Infections and infestations | Lantus | 10 | 228 | 14 |
| other | Influenza | Infections and infestations | HOE901-U300 | 14 | 233 | 17 |
| other | Influenza | Infections and infestations | Lantus | 19 | 228 | 25 |
| other | Nasopharyngitis | Infections and infestations | HOE901-U300 | 37 | 233 | 57 |
| other | Nasopharyngitis | Infections and infestations | Lantus | 39 | 228 | 60 |
| other | Pharyngitis | Infections and infestations | HOE901-U300 | 14 | 233 | 18 |
| other | Pharyngitis | Infections and infestations | Lantus | 22 | 228 | 29 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HOE901-U300 | 1 | 233 |
| Total, all-cause mortality | Lantus | 0 | 228 |
| Total, other adverse events | HOE901-U300 | 105 | 233 |
| Total, other adverse events | Lantus | 118 | 228 |
| Total, serious adverse events | HOE901-U300 | 35 | 233 |
| Total, serious adverse events | Lantus | 31 | 228 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32430458 | DERIVED |
Source PubMed
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/NCT02735044
GET https://conductscience.org/api/trials/v1/NCT02735044/results?page=2