- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02967211
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 (REGAIN CONTROL)
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Curitiba, Brazil, 80810-140
- Investigational Site Number 076-001
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Fortaleza, Brazil
- Investigational Site Number 076004
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Fortaleza, Brazil, 60115-282
- Investigational Site Number 076008
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Rio de Janeiro, Brazil, 202110340
- Investigational Site Number 076009
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Sao Paulo, Brazil, 01244-030
- Investigational Site Number 076-003
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São José dos Campos, Brazil, 12243-280
- Investigational Site Number 076011
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São Paulo, Brazil, 04024-002
- Investigational Site Number 076005
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São paulo, Brazil, 01223-001
- Investigational Site Number 076006
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Taguatinga, Brazil, 72155000
- Investigational Site Number 076010
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Helsinki, Finland, 00100
- Investigational Site Number 246008
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Muurame, Finland, 40930
- Investigational Site Number 246007
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Oulu, Finland, 90100
- Investigational Site Number 246002
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Oulu, Finland, 90220
- Investigational Site Number 246001
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Pori, Finland, 28100
- Investigational Site Number 246009
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Rauma, Finland, 26100
- Investigational Site Number 246004
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Amiens Cedex 1, France, 80054
- Investigational Site Number 250008
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Bordeaux, France, 33000
- Investigational Site Number 250011
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Caen, France, 14000
- Investigational Site Number 250009
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Corbeil Essonnes, France, 91100
- Investigational Site Number 250001
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Eaubonne, France
- Investigational Site Number 250005
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La Rochelle Cedex 1, France, 17019
- Investigational Site Number 250026
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Montpellier, France, 34059
- Investigational Site Number 250020
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Mulhouse, France
- Investigational Site Number 250015
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POITIERS Cedex, France, 86021
- Investigational Site Number 250025
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Paris, France, 75018
- Investigational Site Number 250003
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Pierre-Bénite, France, 69310
- Investigational Site Number 250010
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Pierre-Bénite, France, 69310
- Investigational Site Number 250014
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Valenciennes, France, 59322
- Investigational Site Number 250002
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Vandoeuvre Les Nancy Cedex, France, 54511
- Investigational Site Number 250013
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Athens, Greece, 18454
- Investigational Site Number 300002
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Kalamata, Greece
- Investigational Site Number 300003
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Lamia, Greece, 35100
- Investigational Site Number 300001
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Thessaloniki, Greece, 56429
- Investigational Site Number 300004
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Dublin 4, Ireland
- Investigational Site Number 372003
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Dublin 7, Ireland
- Investigational Site Number 372002
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Arzignano (VI), Italy, 36071
- Investigational Site Number 380033
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Catania, Italy, 95122
- Investigational Site Number 380016
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Catania, Italy
- Investigational Site Number 380004
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Catanzaro, Italy
- Investigational Site Number 380006
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Eboli, Italy, 84025
- Investigational Site Number 380031
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Forlì, Italy
- Investigational Site Number 380007
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Genova, Italy, 16132
- Investigational Site Number 380018
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Iglesias (CI), Italy, 09016
- Investigational Site Number 380020
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Milano, Italy, 20132
- Investigational Site Number 380015
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Milano, Italy, 20162
- Investigational Site Number 380001
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Milano, Italy
- Investigational Site Number 380012
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Orbassano (TO), Italy, 10043
- Investigational Site Number 380011
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Padova, Italy
- Investigational Site Number 380026
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Palermo, Italy, 90127
- Investigational Site Number 380021
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Partinico, Italy, 90047
- Investigational Site Number 380014
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Roma, Italy, 00161
- Investigational Site Number 380002
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Roma, Italy, 00133
- Investigational Site Number 380032
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Roma, Italy
- Investigational Site Number 380023
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San Benedetto del Tronto, Italy, 63074
- Investigational Site Number 380036
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Sarzana, Italy
- Investigational Site Number 380024
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Savigliano (CN), Italy, 12038
- Investigational Site Number 380013
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Sesto S. Giovanni, Italy, 20099
- Investigational Site Number 380017
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Torino, Italy, 10128
- Investigational Site Number 380025
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Arad, Romania
- Investigational Site Number 642008
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Baia MAre, Romania
- Investigational Site Number 642005
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Brasov, Romania, 500326
- Investigational Site Number 642002
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Brasov, Romania, 500326
- Investigational Site Number 642006
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Cluj-Napoca, Romania, 400006
- Investigational Site Number 642003
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Cluj-Napoca, Romania, 400006
- Investigational Site Number 642007
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Targu-Mures, Romania, 540015
- Investigational Site Number 642004
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Timisoara, Romania, 300125
- Investigational Site Number 642001
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Barcelona, Spain, 08035
- Investigational Site Number 724019
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Barcelona, Spain, 08003
- Investigational Site Number 724002
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Barcelona, Spain, 08036
- Investigational Site Number 724012
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Barcelona, Spain
- Investigational Site Number 724011
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Castellón, Spain, 12004
- Investigational Site Number 724027
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Córdoba, Spain, 14004
- Investigational Site Number 724028
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Galdakao (Bilbao), Spain, 48960
- Investigational Site Number 724008
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LLeida, Spain
- Investigational Site Number 724001
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León, Spain, 24071
- Investigational Site Number 724010
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Madrid, Spain, 28007
- Investigational Site Number 724013
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Madrid, Spain
- Investigational Site Number 724018
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Málaga, Spain, 29010
- Investigational Site Number 724020
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Móstoles, Spain, 28933
- Investigational Site Number 724025
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Palma de Mallorca, Spain, 07010
- Investigational Site Number 724006
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Palma de Mallorca, Spain, 07010
- Investigational Site Number 724007
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Pontevedra, Spain, 36071
- Investigational Site Number 724024
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Sabadell, Spain, 08208
- Investigational Site Number 724017
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San Cristóbal De La Laguna - Santa Cruz De Tenerife, Spain, 38320
- Investigational Site Number 724022
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San Juan de Alicante, Spain, 3550
- Investigational Site Number 724003
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Sant Joan Despí, Spain, 08970
- Investigational Site Number 724030
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Santa Cruz de Tenerife, Spain, 38010
- Investigational Site Number 724023
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Santiago de Compostela, Spain, 15706
- Investigational Site Number 724014
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Sevilla, Spain, 41003
- Investigational Site Number 724005
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Sevilla, Spain, 41010
- Investigational Site Number 724016
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Sevilla, Spain, 41071
- Investigational Site Number 724004
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Valencia, Spain, 46010
- Investigational Site Number 724021
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Valladolid, Spain, 47011
- Investigational Site Number 724009
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Vigo, Spain, 36200
- Investigational Site Number 724029
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Bern, Switzerland, 3010
- Investigational Site Number 756003
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St. Gallen, Switzerland, 9007
- Investigational Site Number 756002
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Atherstone, United Kingdom, CV91EU
- Investigational Site Number 826033
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Ayr, United Kingdom, KA66DX
- Investigational Site Number 826016
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Blackburn, United Kingdom, BB21AX
- Investigational Site Number 826039
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Bradford on Avon, United Kingdom, BA151DQ
- Investigational Site Number 826008
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Chertsey, United Kingdom, KT160PZ
- Investigational Site Number 826004
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Cornwall, United Kingdom, PL143XA
- Investigational Site Number 826038
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Coventry, United Kingdom, CV22DX
- Investigational Site Number 826031
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Darlington, United Kingdom, DL36HX
- Investigational Site Number 826024
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Dudley, United Kingdom, DY1 2HQ
- Investigational Site Number 826035
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Glasgow, United Kingdom, G213UW
- Investigational Site Number 826017
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Huntingdon, United Kingdom, PE296JN
- Investigational Site Number 826025
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Liverpool, United Kingdom, L97AL
- Investigational Site Number 826002
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Manchester, United Kingdom, M239LT
- Investigational Site Number 826018
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Manchester, United Kingdom, M85RB
- Investigational Site Number 826019
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Manchester, United Kingdom, M86RB
- Investigational Site Number 826037
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Norwich, United Kingdom, nr34dg
- Investigational Site Number 826023
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Nuneaton, United Kingdom, CV107DJ
- Investigational Site Number 826009
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Plymouth, United Kingdom, PL53JB
- Investigational Site Number 826021
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Portsmouth, United Kingdom, PO63LY
- Investigational Site Number 826006
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Southampton, United Kingdom, SO303JB
- Investigational Site Number 826020
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Taunton, United Kingdom, TA15DA
- Investigational Site Number 826013
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Welwyn Garden City, United Kingdom, AL74HQ
- Investigational Site Number 826007
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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, α 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Toujeo
Toujeo will be administered once daily in addition to non-insulin antidiabetic agents
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Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
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Active Comparator: "Standard of care" commercially available basal insulin
Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents
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Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in HbA1c (percentage %)
Time Frame: Baseline to 6 months
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Baseline to 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Percentage of patients requiring intensification
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Time to intensification
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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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
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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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
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Change in HbA1c (percentage %)
Time Frame: Baseline, Month 12
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Baseline, Month 12
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Percentage of patients whose HbA1c decreased at least 0.5%
Time Frame: At Month 6 and Month 12
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At Month 6 and Month 12
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Percentage of patients whose HbA1c decreased at least 0.5%
Time Frame: At Month 6 and maintained at Month 12
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At Month 6 and maintained at Month 12
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Change in fasting plasma glucose
Time Frame: From baseline to Month 6 and Month 12
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From baseline to Month 6 and Month 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyen-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPS14060
- 2015-001832-39 (EudraCT Number)
- U1111-1170-8132 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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