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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227212
• Other study ID #: PDY14065
• Secondary ID: 2014-001253-16U1
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2014
• Last updated: December 2, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glargine U300 (new formulation of insulin glargine) HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Germany	Investigational Site Number 276011	Augsburg
Germany	Investigational Site Number 276008	Berlin
Germany	Investigational Site Number 276009	Essen
Germany	Investigational Site Number 276002	Hamburg
Germany	Investigational Site Number 276001	Münster
Germany	Investigational Site Number 276007	Potsdam
Germany	Investigational Site Number 276004	Wangen

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease-of-use / ease of learning questionnaire		Day 1, Day 7 , 4-weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4		Baseline, week 4	No
Secondary	Number of participants with Product Technical Complaints (PTC)		Baseline to week 4	Yes
Secondary	Number of participants with adverse events and hypoglycemic events related to PTC		Baseline to week 4	Yes
Secondary	Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)		Baseline, week 4	No
Secondary	Number of participants with adverse events		screening to week 6	Yes
Secondary	Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association		screening to week 6	Yes
Secondary	Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)		screening, baseline, week 4	Yes
Secondary	Number of participants with site injection site reactions / hypersensitivity reactions		baseline to week 6	Yes