Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients withT2DM

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001253-16-DE

Enrollment

Unknown

Registered

2014-06-06

Start date

2014-08-19

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: HOE901 - New Formulation Product Code: HOE901 - New Formulation Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with T2DM inadequately controlled with non-insulin, noninjectable antihyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate. Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Glycated hemoglobin A1c (HbA1c) 11% (97 mmol/mol) at screening. Age 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 antihyperglycemic 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)

Design outcomes

Primary

Measure	Time frame
Main 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 Objective: 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;Primary end point(s): Ease-of-use / ease of learning questionnaire;Timepoint(s) of evaluation of this end point: Day 1, Day 7 , 4-weeks	—

Measure

Time frame

Main 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 Objective: 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;Primary end point(s): Ease-of-use / ease of learning questionnaire;Timepoint(s) of evaluation of this end point: Day 1, Day 7 , 4-weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1) 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 2) Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4 3) Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4 4) Number of participants with Product Technical Complaints (PTC) 5) Number of participants with adverse events and hypoglycemic events related to PTC 6) Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary) 7) Number of participants with adverse events 8) Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association 9) Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG) 10) Number of participants with site injection site reactions / hypersensitivity reactions;Timepoint(s) of evaluation of this end point: 1) 2) 3) 6) Baseline, week 4 4) 5) Baseline to week 4 7) 8) 10) screening to week 6 9) screening, baseline, week 4	—

Measure

Time frame

Secondary end point(s): 1) 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 2) Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4 3) Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4 4) Number of participants with Product Technical Complaints (PTC) 5) Number of participants with adverse events and hypoglycemic events related to PTC 6) Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary) 7) Number of participants with adverse events 8) Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association 9) Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG) 10) Number of participants with site injection site reactions / hypersensitivity reactions;Timepoint(s) of evaluation of this end point: 1) 2) 3) 6) Baseline, week 4 4) 5) Baseline to week 4 7) 8) 10) screening to week 6 9) screening, baseline, week 4

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Countries

Germany

Contacts

Public ContactMedinfo

Sanofi-Aventis Deutschland GmbH

medinfo.de@sanofi.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026