A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

Diabetes Mellitus, Type 2 Clinical Trial

— REGAIN CONTROL  

Official title:

A Twenty-six Week, Randomized, Open-label, 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to "Standard of Care" Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus, With Six-Month Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967211
• Other study ID #: LPS14060
• Secondary ID: 2015-001832-39U1
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2015
• Est. completion date: October 20, 2017

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: - To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change. - To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification. - Risk of hypoglycemia including documented, symptomatic hypoglycemia (≤70 mg/dL) or severe (according to ADA Working Group). - Change in fasting plasma glucose (FPG). - Change in body weight. - Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc). - Change in hypoglycemic control subscale (HCS). - Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.

Description:

The total study duration will be up to 55 weeks, consisting of a 1 week screening period at the site, a 26 week treatment period, and a 26 week extension period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (=6 months) "standard of care" basal insulin therapy (including insulin glargine U100, Levemir, NPH, or Tresiba) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides, a glucosidase inhibitors) and with or without use of a GLP-1 receptor agonist.
• Fasting plasma glucose (FPG) >130 mg/dL (7.2 mmol/L).
• Adult patients who have signed Informed Consent Form (ICF) and privacy form(s).

Exclusion criteria:

• HbA1c =7%, no upper bound.
• Age <18 years.
• Type 1 diabetes mellitus.
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
• Use of any product containing short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization.
• Use of any product containing short or rapid acting insulin occurring within 3 months prior to the time of screening.
• Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening.
• All contraindications to "standard of care" insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products.
• Hypersensitivity to insulin glargine or Toujeo excipients.
• Pregnancy or lactation.
• Women of childbearing potential with no effective contraceptive method. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin glargine (U100)
Pharmaceutical form: solution Route of administration: subcutaneous
• NPH insulin
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin detemir
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin degludec
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Brazil	Investigational Site Number 076-001	Curitiba
Brazil	Investigational Site Number 076004	Fortaleza
Brazil	Investigational Site Number 076008	Fortaleza
Brazil	Investigational Site Number 076009	Rio de Janeiro
Brazil	Investigational Site Number 076011	São José dos Campos
Brazil	Investigational Site Number 076-003	Sao Paulo
Brazil	Investigational Site Number 076005	São Paulo
Brazil	Investigational Site Number 076006	São paulo
Brazil	Investigational Site Number 076010	Taguatinga
Finland	Investigational Site Number 246008	Helsinki
Finland	Investigational Site Number 246007	Muurame
Finland	Investigational Site Number 246001	Oulu
Finland	Investigational Site Number 246002	Oulu
Finland	Investigational Site Number 246009	Pori
Finland	Investigational Site Number 246004	Rauma
France	Investigational Site Number 250008	Amiens Cedex 1
France	Investigational Site Number 250011	Bordeaux
France	Investigational Site Number 250009	Caen
France	Investigational Site Number 250001	Corbeil Essonnes
France	Investigational Site Number 250005	Eaubonne
France	Investigational Site Number 250026	La Rochelle Cedex 1
France	Investigational Site Number 250020	Montpellier
France	Investigational Site Number 250015	Mulhouse
France	Investigational Site Number 250003	Paris
France	Investigational Site Number 250010	Pierre-Bénite
France	Investigational Site Number 250014	Pierre-Bénite
France	Investigational Site Number 250025	POITIERS Cedex
France	Investigational Site Number 250002	Valenciennes
France	Investigational Site Number 250013	Vandoeuvre Les Nancy Cedex
Greece	Investigational Site Number 300002	Athens
Greece	Investigational Site Number 300003	Kalamata
Greece	Investigational Site Number 300001	Lamia
Greece	Investigational Site Number 300004	Thessaloniki
Ireland	Investigational Site Number 372003	Dublin 4
Ireland	Investigational Site Number 372002	Dublin 7
Italy	Investigational Site Number 380033	Arzignano (VI)
Italy	Investigational Site Number 380004	Catania
Italy	Investigational Site Number 380016	Catania
Italy	Investigational Site Number 380006	Catanzaro
Italy	Investigational Site Number 380031	Eboli
Italy	Investigational Site Number 380007	Forlì
Italy	Investigational Site Number 380018	Genova
Italy	Investigational Site Number 380020	Iglesias (CI)
Italy	Investigational Site Number 380001	Milano
Italy	Investigational Site Number 380012	Milano
Italy	Investigational Site Number 380015	Milano
Italy	Investigational Site Number 380011	Orbassano (TO)
Italy	Investigational Site Number 380026	Padova
Italy	Investigational Site Number 380021	Palermo
Italy	Investigational Site Number 380014	Partinico
Italy	Investigational Site Number 380002	Roma
Italy	Investigational Site Number 380023	Roma
Italy	Investigational Site Number 380032	Roma
Italy	Investigational Site Number 380036	San Benedetto del Tronto
Italy	Investigational Site Number 380024	Sarzana
Italy	Investigational Site Number 380013	Savigliano (CN)
Italy	Investigational Site Number 380017	Sesto S. Giovanni
Italy	Investigational Site Number 380025	Torino
Romania	Investigational Site Number 642008	Arad
Romania	Investigational Site Number 642005	Baia MAre
Romania	Investigational Site Number 642002	Brasov
Romania	Investigational Site Number 642006	Brasov
Romania	Investigational Site Number 642003	Cluj-Napoca
Romania	Investigational Site Number 642007	Cluj-Napoca
Romania	Investigational Site Number 642004	Targu-Mures
Romania	Investigational Site Number 642001	Timisoara
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724011	Barcelona
Spain	Investigational Site Number 724012	Barcelona
Spain	Investigational Site Number 724019	Barcelona
Spain	Investigational Site Number 724027	Castellón
Spain	Investigational Site Number 724028	Córdoba
Spain	Investigational Site Number 724008	Galdakao (Bilbao)
Spain	Investigational Site Number 724010	León
Spain	Investigational Site Number 724001	LLeida
Spain	Investigational Site Number 724013	Madrid
Spain	Investigational Site Number 724018	Madrid
Spain	Investigational Site Number 724020	Málaga
Spain	Investigational Site Number 724025	Móstoles
Spain	Investigational Site Number 724006	Palma de Mallorca
Spain	Investigational Site Number 724007	Palma de Mallorca
Spain	Investigational Site Number 724024	Pontevedra
Spain	Investigational Site Number 724017	Sabadell
Spain	Investigational Site Number 724022	San Cristóbal De La Laguna - Santa Cruz De Tenerife
Spain	Investigational Site Number 724003	San Juan de Alicante
Spain	Investigational Site Number 724030	Sant Joan Despí
Spain	Investigational Site Number 724023	Santa Cruz de Tenerife
Spain	Investigational Site Number 724014	Santiago de Compostela
Spain	Investigational Site Number 724004	Sevilla
Spain	Investigational Site Number 724005	Sevilla
Spain	Investigational Site Number 724016	Sevilla
Spain	Investigational Site Number 724021	Valencia
Spain	Investigational Site Number 724009	Valladolid
Spain	Investigational Site Number 724029	Vigo
Switzerland	Investigational Site Number 756003	Bern
Switzerland	Investigational Site Number 756002	St. Gallen
United Kingdom	Investigational Site Number 826033	Atherstone
United Kingdom	Investigational Site Number 826016	Ayr
United Kingdom	Investigational Site Number 826039	Blackburn
United Kingdom	Investigational Site Number 826008	Bradford on Avon
United Kingdom	Investigational Site Number 826004	Chertsey
United Kingdom	Investigational Site Number 826038	Cornwall
United Kingdom	Investigational Site Number 826031	Coventry
United Kingdom	Investigational Site Number 826024	Darlington
United Kingdom	Investigational Site Number 826035	Dudley
United Kingdom	Investigational Site Number 826017	Glasgow
United Kingdom	Investigational Site Number 826025	Huntingdon
United Kingdom	Investigational Site Number 826002	Liverpool
United Kingdom	Investigational Site Number 826018	Manchester
United Kingdom	Investigational Site Number 826019	Manchester
United Kingdom	Investigational Site Number 826037	Manchester
United Kingdom	Investigational Site Number 826023	Norwich
United Kingdom	Investigational Site Number 826009	Nuneaton
United Kingdom	Investigational Site Number 826021	Plymouth
United Kingdom	Investigational Site Number 826006	Portsmouth
United Kingdom	Investigational Site Number 826020	Southampton
United Kingdom	Investigational Site Number 826013	Taunton
United Kingdom	Investigational Site Number 826007	Welwyn Garden City

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  Finland,  France,  Greece,  Ireland,  Italy,  Romania,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (percentage %)		Baseline to 6 months
Secondary	Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)		At Month 6 and Month 12
Secondary	Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not		At Month 6 and Month 12
Secondary	Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)		At Month 6 and Month 12
Secondary	Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose (BG) =70 mg/dl [3.9 mmol/L]) symptomatic or severe		At Month 6 and Month 12
Secondary	Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG <54 mg/dL, [3.0 mmol/L]) symptomatic or severe hypoglycemia		At Month 6 and Month 12
Secondary	Change in HbA1c (percentage %)		Baseline, Month 12
Secondary	Percentage of patients whose HbA1c decreased at least 0.5%		At Month 6 and Month 12
Secondary	Percentage of patients whose HbA1c decreased at least 0.5%		At Month 6 and maintained at Month 12
Secondary	Percentage of patients requiring intensification		At Month 6 and Month 12
Secondary	Time to intensification		At Month 6 and Month 12
Secondary	Change in fasting plasma glucose		From baseline to Month 6 and Month 12