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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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ClinicalTrials.gov Identifier: NCT02227212
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin glargine U300
Once daily subcutaneous injection for 4 weeks
Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Ease-of-use / ease of learning questionnaire [ Time Frame: Day 1, Day 7 , 4-weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4 [ Time Frame: Baseline, week 4 ]
  4. Number of participants with Product Technical Complaints (PTC) [ Time Frame: Baseline to week 4 ]
  5. Number of participants with adverse events and hypoglycemic events related to PTC [ Time Frame: Baseline to week 4 ]
  6. Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary) [ Time Frame: Baseline, week 4 ]
  7. Number of participants with adverse events [ Time Frame: screening to week 6 ]
  8. 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 ]
  9. Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG) [ Time Frame: screening, baseline, week 4 ]
  10. Number of participants with site injection site reactions / hypersensitivity reactions [ Time Frame: baseline to week 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227212


Locations
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Germany
Investigational Site Number 276011
Augsburg, Germany, 86150
Investigational Site Number 276008
Berlin, Germany, 10115
Investigational Site Number 276009
Essen, Germany, 45355
Investigational Site Number 276002
Hamburg, Germany, 22607
Investigational Site Number 276001
Münster, Germany, 48145
Investigational Site Number 276007
Potsdam, Germany, 14469
Investigational Site Number 276004
Wangen, Germany, 88239
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02227212     History of Changes
Other Study ID Numbers: PDY14065
2014-001253-16
U1111-1155-7309 ( Other Identifier: UTN )
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs