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Completed

NCT Number: NCT02855684

Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

Primary Objective:

To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus.

Secondary Objectives:

* To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. * To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). * To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). * To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). * To assess the safety and tolerability of insulin glargine (U300). * To assess the development of anti-insulin glargine antibodies (AIA).

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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 3

Primary location

Investigational Site Number 1560001, Beijing, China

Loading trial locations.

About this study

The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety 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 inadequately controlled with non-insulin antihyperglycemic drug(s).
  • Signed written informed consent.

Exclusion criteria

  • Age < legal age of adulthood.
  • HbA1c <7.0% (<53 mmol/mol) or >11% (>97 mmol/mol) (at screening).
  • History of type 2 diabetes mellitus for less than 1 year before screening.
  • Less than 6 months before screening with non-insulin antihyperglycemic treatment.
  • Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening.
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit.
  • Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization).
  • Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening.
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
  • 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)

Drug

Pharmaceutical form: solution

Route of administration: subcutaneous

Other names: HOE901; Toujeo

insulin glargine

Drug

Pharmaceutical form: solution

Route of administration: subcutaneous

Other names: HOE901; Lantus

Non-insulin antihyperglycemic drugs

Drug

Pharmaceutical form: capsule/tablet

Route of administration: oral

Other names: Non-insulin antihyperglycemic therapy

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Percentage (%) of patients with at least one hypoglycemia

    Time frame: Baseline, up to 6 months

  2. Percentage (%) of patients with at least one nocturnal hypoglycemia

    Time frame: Baseline, up to 6 months

  3. Percentage (%) of patients with HbA1c <7.0%

    Time frame: 6 months

  4. Percentage (%) of patients with HbA1c ≤6.5%

    Time frame: 6 months

  5. Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)

    Time frame: 6 months

  6. Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)

    Time frame: 6 months

  7. Percentage (%) of patients requiring rescue therapy

    Time frame: 6 months

  8. Change in fasting plasma glucose

    Time frame: Baseline, 6 months

  9. Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles

    Time frame: Baseline, 6 months

  10. Change of mean 24-hour plasma glucose

    Time frame: Baseline, 6 months

  11. Change in variability of plasma glucose profile

    Time frame: Baseline, 6 months

  12. Change in daily basal insulin dose

    Time frame: Baseline, 6 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs

Acronym: EDITION AP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 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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