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Completed

NCT Number: NCT03703869

Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

* Assess effectiveness in achieving glycemic goal measured by HbA1c; * Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; * Assess requirement for intensification of therapy by additional antidiabetics. * Assess incidence of hypoglycemia; * Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); * Assess change in body weight.

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Key information

Conditions

Diabetes 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

Observational

Primary location

Investigational Site Number 1700001, Barranquilla, Colombia

Loading trial locations.

About this study

Patients will be observed for one year

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed patient informed consent;
  • Type 2 diabetes mellitus;
  • Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
  • Hemoglobin A1c (HbA1c) >7.0 % and ≤11% within 3 months of study baseline;
  • Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria

  • Diabetes mellitus other than type 2;
  • Contraindication to insulin glargine U300 according to local product labelling;

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 for injection

Route of administration: Subcutaneous injection

Other names: HOE901, Toujeo, Toujeo Solostar

Primary outcomes

  1. Change in HbA1c at month 6

    Time frame: Baseline, month 6

    Percentage of patients achieving Hemoglobin A1c <7.0%.

Secondary outcomes

  1. Change in HbA1c

    Time frame: Baseline, months 3, 6, 12

    Change from baseline in HbA1c at 3, 6, and 12 months

  2. Change in fasting plasma glucose

    Time frame: Baseline, months 3, 6, 12

    Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months

  3. Change in Self-Monitored Plasma Glucose

    Time frame: Baseline, months 3, 6, 12

    Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months

  4. Hypoglycemia

    Time frame: Baseline to month 12

    Number of participants with symptomatic hypoglycemic events

  5. Adverse events

    Time frame: Baseline to month 12

    Number of participants with Adverse Events

  6. Serious adverse events

    Time frame: Baseline to month 12

    Number of participants with Serious Adverse Events

  7. Body weight

    Time frame: Baseline to month 12

    Change in average body weight

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus

Acronym: ATOS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 12, 2018
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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