A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

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• Diabetes Mellitus, Type 1 3,614

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 638 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Study arms

• Experimental
  HOE901-U300

  HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

  Drug: HOE901-U300 (Insulin Glargine 300 U/ml) · Drug: Mandated back ground therapy

• Active comparator
  Lantus

  Lantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.

  Drug: Lantus (Insulin Glargine 100 U/ml) · Drug: Mandated back ground therapy

Interventions

• DrugHOE901-U300 (Insulin Glargine 300 U/ml)

  Drug page: Insulin Glargine

  Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.

  Also known as: Toujeo

• DrugLantus (Insulin Glargine 100 U/ml)

  Drug page: Insulin Glargine

  Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.

  Also known as: HOE901-U100

• DrugMandated back ground therapy

  Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Primary outcomes

1. Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM

   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).

   Time frame: During Week 15 and/or 16

Secondary outcomes

1. Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia

   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).

   Time frame: Baseline up to Week 16

2. Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year

   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.

   Time frame: Baseline up to Week 16

3. 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

   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).

   Time frame: Baseline, during Week 15 and/or Week 16

4. 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

   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).

   Time frame: During Week 15 and/or Week 16

5. Coefficient of Variation (CV%) in Mean CGM Glucose

   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.

   Time frame: During Week 15 and/or Week 16

Other outcomes

1. Change From Baseline in Daily Insulin Dose at Week 16

   Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.

   Time frame: Baseline, Week 16

Baseline characteristics

Study documents

• Study protocol · Aug 2, 2016
• Statistical analysis plan · Jul 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org