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

Study Overview
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Brief Summary
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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
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The total study duration for a participants can be approximately up to 10 weeks.

Official Title
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A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate. Signed written informed consent. Exclusion criteria: Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening. Age <18 years at the time of screening. Body Mass Index (BMI) >40 kg/m2. Diabetes other than T2DM. History of T2DM for less than 1 year before screening. Less than 6 months anti-hyperglycemic treatment before screening. Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit. Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist. Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides. Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening. Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients. Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling. Latest eye examination by an ophthalmologist >12 months prior to inclusion. More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months. Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine U300<br>Once daily subcutaneous injection for 4 weeks | Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease-of-use / ease of learning questionnaire |  | Day 1, Day 7 , 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |