Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 19.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005101-36-BG
• Lead Sponsor: sanofi-aventis Groupe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-19
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1840

Inclusion Criteria

-Adult patients with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
-Signed written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 460

Exclusion Criteria

-Age <18 years.
-HbA1c <7.5% or >10.5% (at screening visit).
-Body mass index (BMI) <25 kg/m^2 or >40 kg/m^2.
-History of T2DM for less than 1 year before screening.
-Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
-Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
-Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
-Patient receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
-History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
-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.
-End stage renal disease.
-Any acute or chronic condition that in the opinion of Investigator would affect the patient safety, compliance, or study results.
-Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
-Pregnant or breast-feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified