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

NCT02967237 | Completed Phase 4

• 3 other identifiers: GLARGL076672015-002416-33U1111-1176-6203
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 85

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in HbA1c

  Baseline, Week 24

Secondary Outcomes (8)

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

  At Weeks 12 and 24

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

  At Week 24

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

  Baseline to Week 12 and Week 24

• Mean change from baseline in fasting plasma glucose

  Baseline to Week 12 and Week 24

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

  Baseline to Week 24

Study Arms (1)

Insulin glargine (U300)

EXPERIMENTAL

Type 2 diabetes mellitus patients uncontrolled with their current basal insulin therapy switched according to the physician decision, to insulin glargine (U300) administered subcutaneously and once daily using a pre-filled pen

Drug: insulin glargine (U300)

Interventions

insulin glargine (U300) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: HOE901; Toujeo

Insulin glargine (U300)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (85)

Investigational Site Number 250017

Alençon, 61014, France

Location

Investigational Site Number 250073

Alès, 30100, France

Location

Investigational Site Number 250047

Amiens, 80054, France

Location

Investigational Site Number 250028

Amilly, France

Location

Investigational Site Number 250062

Bagnols-sur-Cèze, France

Location

Investigational Site Number 250093

Bar-le-Duc, France

Location

Investigational Site Number 250020

Besançon, 25030, France

Location

Investigational Site Number 250081

Béthune, 62408, France

Location

Investigational Site Number 250034

Bondy, 93143, France

Location

Investigational Site Number 250022

Brest, 29000, France

Location

Investigational Site Number 250070

Brest, 29610, France

Location

Investigational Site Number 250060

Cahors, 46005, France

Location

Investigational Site Number 250096

Cannes, 06401, France

Location

Investigational Site Number 250072

Chambéry, 73000, France

Location

Investigational Site Number 250037

Châlons-en-Champagne, 51005, France

Location

Investigational Site Number 250018

Cholet, 49300, France

Location

Investigational Site Number 250068

Clermont-Ferrand, 63000, France

Location

Investigational Site Number 250098

Cognac, 16112, France

Location

Investigational Site Number 250048

Colmar, 68024, France

Location

Investigational Site Number 250088

Contamines Sur Arve, 74130, France

Location

Investigational Site Number 250054

Coudray, 28630, France

Location

Investigational Site Number 250063

Dijon, 21000, France

Location

Investigational Site Number 250013

Eaubonne, France

Location

Investigational Site Number 250095

Étampes, France

Location

Investigational Site Number 250104

Grenoble, 38043, France

Location

Investigational Site Number 250004

La Roche-sur-Yon, 85025, France

Location

Investigational Site Number 250002

La Rochelle, 17019, France

Location

Investigational Site Number 250019

La Seyne-sur-Mer, France

Location

Investigational Site Number 250030

Lamagistère, 82360, France

Location

Investigational Site Number 250103

Le Chesnay, 78157, France

Location

Investigational Site Number 250053

Le Creusot, 71200, France

Location

Investigational Site Number 250044

Le Mans, 72037, France

Location

Investigational Site Number 250056

Lens, France

Location

Investigational Site Number 250051

Lourdes, 65000, France

Location

Investigational Site Number 250071

Mantes-la-Jolie, France

Location

Investigational Site Number 250092

Marseille, 13006, France

Location

Investigational Site Number 250064

Marseille, 13008, France

Location

Investigational Site Number 250089

Maubeuge, 59600, France

Location

Investigational Site Number 250083

Mérignac, 33700, France

Location

Investigational Site Number 250035

Montpellier, 34000, France

Location

Investigational Site Number 250061

Montpellier, 34059, France

Location

Investigational Site Number 250010

Montpellier, 34295, France

Location

Investigational Site Number 250008

Montpellier, France

Location

Investigational Site Number 250032

Mulhouse, France

Location

Investigational Site Number 250043

Nancy, France

Location

Investigational Site Number 250005

Narbonne, 11018, France

Location

Investigational Site Number 250069

Nevers, 58000, France

Location

Investigational Site Number 250052

Nîmes, 30029, France

Location

Investigational Site Number 250059

Noisy-le-Grand, France

Location

Investigational Site Number 250058

Orléans, 45100, France

Location

Investigational Site Number 250031

Paris, 75008, France

Location

Investigational Site Number 250105

Paris, 75012, France

Location

Investigational Site Number 250086

Paris, 75014, France

Location

Investigational Site Number 250026

Paris, 75020, France

Location

Investigational Site Number 250101

Pessac, 33604, France

Location

Investigational Site Number 250084

Périgueux, 24019, France

Location

Investigational Site Number 250107

Pointe à Pitre, 97159, France

Location

Investigational Site Number 250067

Pontoise, 95300, France

Location

Investigational Site Number 250078

Pringy, 74374, France

Location

Investigational Site Number 250042

Reims, 51092, France

Location

Investigational Site Number 250012

Roubaix, 59100, France

Location

Investigational Site Number 250055

Roubaix, 59100, France

Location

Investigational Site Number 250102

Saint-Brieuc, France

Location

Investigational Site Number 250065

Saint-Denis, 93200, France

Location

Investigational Site Number 250029

Saint-Mandé, 94160, France

Location

Investigational Site Number 250108

Saint-Pierre, 97448, France

Location

Investigational Site Number 250087

Seclin, 59113, France

Location

Investigational Site Number 250090

Sète, 34200, France

Location

Investigational Site Number 250006

Strasbourg, 67000, France

Location

Investigational Site Number 250024

Strasbourg, 67098, France

Location

Investigational Site Number 250033

Suresnes, 92150, France

Location

Investigational Site Number 250057

Tarbes, 65013, France

Location

Investigational Site Number 250001

Toulouse, 31000, France

Location

Investigational Site Number 250076

Toulouse, 31027, France

Location

Investigational Site Number 250082

Toulouse, 31076, France

Location

Investigational Site Number 250050

Toulouse, 31100, France

Location

Investigational Site Number 250027

Tours, 37000, France

Location

Investigational Site Number 250075

Tours, 37000, France

Location

Investigational Site Number 250041

Valenciennes, 59322, France

Location

Investigational Site Number 250021

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number 250023

Vénissieux, 69200, France

Location

Investigational Site Number 250039

Vichy, 03200, France

Location

Investigational Site Number 250046

Vichy, 03201, France

Location

Investigational Site Number 250100

Villeneuve-sur-Lot, 47300, France

Location

Investigational Site Number 250007

Warloy-Baillon, 80300, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: January 4, 2016
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (85)