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

Primary Purpose

Diabetes Mellitus Type 2

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Insulin glargine U300 (new formulation of insulin glargine) HOE901

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 276011
Investigational Site Number 276008
Investigational Site Number 276009
Investigational Site Number 276002
Investigational Site Number 276001
Investigational Site Number 276007
Investigational Site Number 276004

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulin glargine U300

Arm Description

Once daily subcutaneous injection for 4 weeks

Outcomes

Primary Outcome Measures

Ease-of-use / ease of learning questionnaire

Secondary Outcome Measures

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

Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4

Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4

Number of participants with Product Technical Complaints (PTC)

Number of participants with adverse events and hypoglycemic events related to PTC

Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)

Number of participants with adverse events

Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association

Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)

Number of participants with site injection site reactions / hypersensitivity reactions

Full Information

NCT ID

NCT02227212

First Posted

August 26, 2014

Last Updated

December 2, 2014

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02227212

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin glargine U300

Arm Type

Experimental

Arm Description

Once daily subcutaneous injection for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Insulin glargine U300 (new formulation of insulin glargine) HOE901

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Ease-of-use / ease of learning questionnaire

Time Frame

Day 1, Day 7 , 4-weeks

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4

Time Frame

Baseline, week 4

Title

Number of participants with Product Technical Complaints (PTC)

Time Frame

Baseline to week 4

Title

Number of participants with adverse events and hypoglycemic events related to PTC

Time Frame

Baseline to week 4

Title

Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)

Time Frame

Baseline, week 4

Title

Number of participants with adverse events

Time Frame

screening to week 6

Title

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

Title

Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)

Time Frame

screening, baseline, week 4

Title

Number of participants with site injection site reactions / hypersensitivity reactions

Time Frame

baseline to week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 276011

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

Investigational Site Number 276008

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Investigational Site Number 276009

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Investigational Site Number 276002

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Investigational Site Number 276001

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Investigational Site Number 276007

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Investigational Site Number 276004

City

Wangen

ZIP/Postal Code

88239

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27664062

Citation

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.

Results Reference

derived

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

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