A 12-week randomized, controlled trial to compare TOUJEO® and TRESIBA® in terms of glucose values in target range and variability during continuous glucose monitoring in patients with type 1 diabetes mellitus

Phase 4

Completed

Conditions: Diabetes Type I
glucose values
10012653

Registration Number: NL-OMON48426

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Participants with Type 1 Diabetes mellitus (T1DM)

Participants treated with multiple daily injections (MDI) using basal insulin
analog once daily and rapid acting insulin analogs for at least one year

HbA1c * 7% (48 mmol/mol) and * 10% (86 mmol/mol) at screening

Exclusion Criteria

Participants not on stable dose of basal insulin analog

Participants having received Toujeo or Tresiba as basal insulin within 30 days
prior to screening

Participants not using the same insulins (both basal and rapid) within 30 days
prior to screening

Participants having received basal insulin dose *0.6 U/kg body weight within 30
days prior to screening

Participants having received any glucose lowering drugs (including any premixed
insulins,human regular insulin as mealtime insulins, any others injectable or
oral), other than basal and rapid insulin analogs, within 3 months prior to
screening

End stage renal disease or on renal replacement treatment

Retinopathy or maculopathy with one of the following treatments, either recent
(within 3 months prior to screening) or planned: intravitreal injections or
laser or vitrectomy surgery

Body weight change *5 kg within 3 months prior to screening

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percent time in glucose range of 70 to 180 mg/dL (3.9 to<br /><br>10 mmol/L) at Week 12, obtained using continuous glucose<br /><br>monitoring (CGM)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At Week 12, the following endpoints will be assessed:<br /><br>* Glucose total CV<br /><br>* Glucose within-day and between-day CV<br /><br>Other secondary endpoints:<br /><br>* Change from baseline to Week 12 in HbA1c<br /><br>* Change from baseline to Week 12 in central lab FPG<br /><br>* Percent time and mean hours per day with<br /><br>glucose<70mg/dL (on all time and during the night<br /><br>[00:00 to 05:59])<br /><br>* Percent time and mean hours per day with<br /><br>glucose>180mg/dL<br /><br>Number of participants with adverse events (see Section 8.3)<br /><br>Number of participants with at least one hypoglycemic event<br /><br>from baseline to Week 12<br /><br>Number of hypoglycemic events per participant year from<br /><br>baseline to Week 12</p><br>