- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02227212
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Augsburg, Germany, 86150
- Investigational Site Number 276011
-
Berlin, Germany, 10115
- Investigational Site Number 276008
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Essen, Germany, 45355
- Investigational Site Number 276009
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Hamburg, Germany, 22607
- Investigational Site Number 276002
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Münster, Germany, 48145
- Investigational Site Number 276001
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Potsdam, Germany, 14469
- Investigational Site Number 276007
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Wangen, Germany, 88239
- Investigational Site Number 276004
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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