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OpenTrials
Completed

NCT Number: NCT02967237

Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment

Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

* Evolution of fasting plasma glucose * Evolution of insulin dose and body weight * Hypoglycemia incidence * Safety * Patients satisfaction when they change their insulin for HOE901-U300

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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 4

Primary location

Investigational Site Number 250017, Alençon, France

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About this study

The total study duration per patient is approximately 28 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (GLP-1) receptor agonist
  • HbA1c > 7.5%

Exclusion criteria

  • Patients with high dose of insulin (>1.2 U/kg)
  • Use of prandial insulin
  • Change of dose of antidiabetic drugs within the last 8 weeks
  • Use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks

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)

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

Other names: HOE901; Toujeo

Primary outcomes

  1. Mean change from baseline in HbA1c

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)

    Time frame: At Weeks 12 and 24

  2. Percentage of patients with HbA1c <7%, <7.5%, and <8%

    Time frame: At Week 24

  3. Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)

    Time frame: Baseline to Week 12 and Week 24

  4. Mean change from baseline in fasting plasma glucose

    Time frame: Baseline to Week 12 and Week 24

  5. Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame: Baseline to Week 24

  6. Change in Diabetes Treatment Satisfaction Questionnaire score

    Time frame: Week 24

  7. Number of hypoglycemic events

    Time frame: From inclusion up to Week 24

  8. Number of adverse events

    Time frame: From inclusion up to Week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Acronym: Transition II

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2016
Registry last updated
Apr 25, 2022

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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