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Completed

NCT Number: NCT02227212

Ease of Use and Safety of the 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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number 276011, Augsburg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin glargine U300 (new formulation of insulin glargine) HOE901

Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary outcomes

  1. Ease-of-use / ease of learning questionnaire

    Time frame: Day 1, Day 7 , 4-weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 28, 2014
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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