Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901

• Registration Number: NCT02227212
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.

Secondary Objectives:

To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.

The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.

Detailed Description

The total study duration for a participants can be approximately up to 10 weeks.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insulin glargine U300	Insulin glargine U300 (new formulation of insulin glargine) HOE901	Once daily subcutaneous injection for 4 weeks

Primary Outcome Measures

Name	Time	Method
Ease-of-use / ease of learning questionnaire	Day 1, Day 7 , 4-weeks

Secondary Outcome Measures

Name	Time	Method
Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4	Baseline, week 4
Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4	Baseline, week 4
Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4	Baseline, week 4
Number of participants with Product Technical Complaints (PTC)	Baseline to week 4
Number of participants with adverse events and hypoglycemic events related to PTC	Baseline to week 4
Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)	Baseline, week 4
Number of participants with adverse events	screening to week 6
Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association	screening to week 6
Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)	screening, baseline, week 4
Number of participants with site injection site reactions / hypersensitivity reactions	baseline to week 6

Trial Locations

Locations (7)

Investigational Site Number 276008; 🇩🇪 Berlin, Germany

Investigational Site Number 276011; 🇩🇪 Augsburg, Germany

Investigational Site Number 276009; 🇩🇪 Essen, Germany

Investigational Site Number 276002; 🇩🇪 Hamburg, Germany

Investigational Site Number 276007; 🇩🇪 Potsdam, Germany

Investigational Site Number 276001; 🇩🇪 Münster, Germany

Investigational Site Number 276004; 🇩🇪 Wangen, Germany