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

December 2, 2014 updated by: Sanofi

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

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.

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Augsburg, Germany, 86150
        • Investigational Site Number 276011
      • Berlin, Germany, 10115
        • Investigational Site Number 276008
      • Essen, Germany, 45355
        • Investigational Site Number 276009
      • Hamburg, Germany, 22607
        • Investigational Site Number 276002
      • Münster, Germany, 48145
        • Investigational Site Number 276001
      • Potsdam, Germany, 14469
        • Investigational Site Number 276007
      • Wangen, Germany, 88239
        • Investigational Site Number 276004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin glargine U300
Once daily subcutaneous injection for 4 weeks
Pharmaceutical form:solution for injection Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Baseline, 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
Time Frame: Baseline, week 4
Baseline, week 4
Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
Time Frame: Baseline, week 4
Baseline, week 4
Number of participants with Product Technical Complaints (PTC)
Time Frame: Baseline to week 4
Baseline to week 4
Number of participants with adverse events and hypoglycemic events related to PTC
Time Frame: Baseline to week 4
Baseline to week 4
Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)
Time Frame: Baseline, week 4
Baseline, week 4
Number of participants with adverse events
Time Frame: screening to week 6
screening to week 6
Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association
Time Frame: screening to week 6
screening to week 6
Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)
Time Frame: screening, baseline, week 4
screening, baseline, week 4
Number of participants with site injection site reactions / hypersensitivity reactions
Time Frame: baseline to week 6
baseline to week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • PDY14065
  • 2014-001253-16
  • U1111-1155-7309 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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