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Completed

NCT Number: NCT02954692

A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

Primary Objective:

To assess the mean change in HbA1c (glycated haemoglobin).

Secondary Objectives:

To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:

* Targeted HbA1c; * Targeted fasting self- monitoring blood glucose (SMBG); * Hypoglycemic events; * Adverse events; * Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change); * Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.

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Key information

Conditions

Type 2 Diabetes Mellitus 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 4

Primary location

Turkey, Turkey (Türkiye)

About this study

The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients with type 2 diabetes mellitus (≥18 years of age).
  • Type 2 diabetes mellitus diagnosis ≥1 year.
  • Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve).
  • Stable antidiabetic treatment for at least 3 months.
  • Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose [SMBG]).
  • Signed informed consent obtained.

Exclusion criteria

  • Age <18 years old.
  • Type 1 diabetes mellitus.
  • Having secondary type 2 diabetes mellitus.
  • Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis.
  • History of hypoglycemia unawareness.
  • Known hypersensitivity/intolerance to insulin glargine or any of its excipients.
  • Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol.
  • Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening.
  • Pregnant or lactating women.
  • Participation in another clinical trial.

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: pen for injection

Route of administration: subcutaneous

Other names: HOE901

metformin

Drug

Pharmaceutical form: tablet

Route of administration: oral

Sulfonylurea

Drug

Pharmaceutical form: tablet

Route of administration: oral

Meglitinides

Drug

Pharmaceutical form: tablet

Route of administration: oral

Thiazolidinediones

Drug

Pharmaceutical form: tablet

Route of administration: oral

Alpha-glucosidase inhibitors

Drug

Pharmaceutical form: tablet

Route of administration: oral

GLP1 receptor agonist

Drug

Pharmaceutical form: pen for injection

Route of administration: subcutaneous

Dipeptidyl peptidase-IV (DPP-IV) inhibitors

Drug

Pharmaceutical form: tablet

Route of administration: oral

Sodium-glucose transport-2 (SGLT-2) inhibitors

Drug

Pharmaceutical form: tablet

Route of administration: oral

Primary outcomes

  1. Mean change from baseline in HbA1c

    Time frame: Baseline, Week 24

Secondary outcomes

  1. Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL

    Time frame: At Weeks 12 and 24

  2. Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)

    Time frame: At Weeks 12 and 24

  3. Duration to reach target pre-breakfast SMBG

    Time frame: Baseline, Week 24

  4. Mean change from baseline in HbA1c

    Time frame: Baseline, Week 12

  5. Mean change from baseline in SMBG

    Time frame: Baseline, Weeks 12, and 24

  6. Mean change from baseline in fasting plasma glucose (FPG)

    Time frame: Baseline, Weeks 12, and 24

  7. Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores

    Time frame: Baseline, Week 24

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey

Acronym: EASE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Jan 14, 2019

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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