Clinical trial NCT02967237: Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
Official title: An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The total study duration per patient is approximately 28 weeks.

Eligibility criteria: Inclusion criteria :

* 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%

Exclusion criteria:

* 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.

Primary outcomes:
measure: Mean change from baseline in HbA1c
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of patients who reach target fasting plasma glucose (90-130 mg/dL)
timeFrame: At Weeks 12 and 24
measure: Percentage of patients with HbA1c <7%, <7.5%, and <8%
timeFrame: At Week 24
measure: Mean change from baseline in HbA1c across HbA1c subgroups category (≤8%, >8 to 9%, and >9%)
timeFrame: Baseline to Week 12 and Week 24
measure: Mean change from baseline in fasting plasma glucose
timeFrame: Baseline to Week 12 and Week 24
measure: Assessment of patient reported outcomes (satisfaction on treatment and perception of hypoglycemia/hyperglycemia) based on the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: Baseline to Week 24
measure: Change in Diabetes Treatment Satisfaction Questionnaire score
timeFrame: Week 24
measure: Number of hypoglycemic events
timeFrame: From inclusion up to Week 24
measure: Number of adverse events
timeFrame: From inclusion up to Week 24
Other outcomes:
Locations:
city: Alencon Cedex
country: France
facility: Investigational Site Number 250017
city: Ales
country: France
facility: Investigational Site Number 250073
city: Amiens Cedex 1
country: France
facility: Investigational Site Number 250047
city: Amilly
country: France
facility: Investigational Site Number 250028
city: Bagnols-sur-Cèze
country: France
facility: Investigational Site Number 250062
city: Bar le Duc
country: France
facility: Investigational Site Number 250093
city: Besancon
country: France
facility: Investigational Site Number 250020
city: BETHUNE Cedex
country: France
facility: Investigational Site Number 250081
city: Bondy
country: France
facility: Investigational Site Number 250034
city: Brest Cedex
country: France
facility: Investigational Site Number 250070
city: Brest
country: France
facility: Investigational Site Number 250022
city: CAHORS Cedex 9
country: France
facility: Investigational Site Number 250060
city: Cannes
country: France
facility: Investigational Site Number 250096
city: CHALONS EN CHAMPAGNE Cedex
country: France
facility: Investigational Site Number 250037
city: Chambery
country: France
facility: Investigational Site Number 250072
city: Cholet
country: France
facility: Investigational Site Number 250018
city: Clermont Ferrand
country: France
facility: Investigational Site Number 250068
city: Cognac
country: France
facility: Investigational Site Number 250098
city: Colmar
country: France
facility: Investigational Site Number 250048
city: Contamines Sur Arve
country: France
facility: Investigational Site Number 250088
city: Coudray
country: France
facility: Investigational Site Number 250054
city: Dijon
country: France
facility: Investigational Site Number 250063
city: Eaubonne
country: France
facility: Investigational Site Number 250013
city: Etampes
country: France
facility: Investigational Site Number 250095
city: Grenoble
country: France
facility: Investigational Site Number 250104
city: La Roche Sur Yon
country: France
facility: Investigational Site Number 250004
city: La Rochelle Cedex 1
country: France
facility: Investigational Site Number 250002
city: La Seyne sur Mer
country: France
facility: Investigational Site Number 250019
city: Lamagistere
country: France
facility: Investigational Site Number 250030
city: LE CHESNAY Cedex
country: France
facility: Investigational Site Number 250103
city: Le Creusot
country: France
facility: Investigational Site Number 250053
city: Le Mans Cedex 9
country: France
facility: Investigational Site Number 250044
city: Lens
country: France
facility: Investigational Site Number 250056
city: Lourdes
country: France
facility: Investigational Site Number 250051
city: Mantes La Jolie
country: France
facility: Investigational Site Number 250071
city: Marseille
country: France
facility: Investigational Site Number 250092
city: Marseille
country: France
facility: Investigational Site Number 250064
city: Maubeuge
country: France
facility: Investigational Site Number 250089
city: Merignac
country: France
facility: Investigational Site Number 250083
city: Montpellier
country: France
facility: Investigational Site Number 250035
city: Montpellier
country: France
facility: Investigational Site Number 250061
city: Montpellier
country: France
facility: Investigational Site Number 250010
city: Montpellier
country: France
facility: Investigational Site Number 250008
city: Mulhouse
country: France
facility: Investigational Site Number 250032
city: Nancy
country: France
facility: Investigational Site Number 250043
city: NARBONNE Cedex
country: France
facility: Investigational Site Number 250005
city: Nevers
country: France
facility: Investigational Site Number 250069
city: Nimes
country: France
facility: Investigational Site Number 250052
city: Noisy Le Grand
country: France
facility: Investigational Site Number 250059
city: Orleans
country: France
facility: Investigational Site Number 250058
city: Paris
country: France
facility: Investigational Site Number 250031
city: Paris
country: France
facility: Investigational Site Number 250105
city: Paris
country: France
facility: Investigational Site Number 250086
city: Paris
country: France
facility: Investigational Site Number 250026
city: PERIGUEUX Cedex
country: France
facility: Investigational Site Number 250084
city: Pessac Cedex
country: France
facility: Investigational Site Number 250101
city: Pointe À Pitre
country: France
facility: Investigational Site Number 250107
city: Pontoise
country: France
facility: Investigational Site Number 250067
city: PRINGY Cedex
country: France
facility: Investigational Site Number 250078
city: Reims Cedex
country: France
facility: Investigational Site Number 250042
city: Roubaix
country: France
facility: Investigational Site Number 250012
city: Roubaix
country: France
facility: Investigational Site Number 250055
city: Saint Brieuc
country: France
facility: Investigational Site Number 250102
city: Saint Pierre
country: France
facility: Investigational Site Number 250108
city: Saint-Denis
country: France
facility: Investigational Site Number 250065
city: Saint-Mandé
country: France
facility: Investigational Site Number 250029
city: Seclin
country: France
facility: Investigational Site Number 250087
city: Sete
country: France
facility: Investigational Site Number 250090
city: Strasbourg Cedex 2
country: France
facility: Investigational Site Number 250024
city: Strasbourg
country: France
facility: Investigational Site Number 250006
city: Suresnes
country: France
facility: Investigational Site Number 250033
city: Tarbes
country: France
facility: Investigational Site Number 250057
city: Toulouse Cedex 3
country: France
facility: Investigational Site Number 250082
city: Toulouse
country: France
facility: Investigational Site Number 250001
city: Toulouse
country: France
facility: Investigational Site Number 250076
city: Toulouse
country: France
facility: Investigational Site Number 250050
city: Tours
country: France
facility: Investigational Site Number 250027
city: Tours
country: France
facility: Investigational Site Number 250075
city: Valenciennes
country: France
facility: Investigational Site Number 250041
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Investigational Site Number 250021
city: Venissieux
country: France
facility: Investigational Site Number 250023
city: VICHY Cedex
country: France
facility: Investigational Site Number 250046
city: Vichy
country: France
facility: Investigational Site Number 250039
city: Villeneuve sur Lot
country: France
facility: Investigational Site Number 250100
city: Warloy Baillon
country: France
facility: Investigational Site Number 250007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: