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

NCT ID: NCT02227212

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin glargine U300

Once daily subcutaneous injection for 4 weeks

Group Type: EXPERIMENTAL

Insulin glargine U300 (new formulation of insulin glargine) HOE901

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Interventions

Insulin glargine U300 (new formulation of insulin glargine) HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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, , Germany

Countries

Germany

References

Pohlmeier H, Berard L, Brulle-Wohlhueter C, Wu J, Dahmen R, Nowotny I, Klonoff D. Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naive People With Type 2 Diabetes. J Diabetes Sci Technol. 2017 Mar;11(2):263-269. doi: 10.1177/1932296816668877. Epub 2016 Sep 25.

Reference Type: DERIVED

PMID: 27664062 (View on PubMed)

Other Identifiers

2014-001253-16

Identifier Type: -

Identifier Source: secondary_id

U1111-1155-7309

Identifier Type: OTHER

Identifier Source: secondary_id

PDY14065

Identifier Type: -

Identifier Source: org_study_id