Diabetes Mellitus, Type 2Phase 4REGAIN CONTROLNCT02967211
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
A Phase 4 study testing insulin glargine (U300), insulin glargine (U100) and NPH insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 118 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- insulin glargine (U300), insulin glargine (U100) and NPH insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 609 participants
- Where
- 118 sitesin 10 countries
- Study dates
- 21 Dec 2015to 20 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
118 sites in 10 countries.
118 sites in 10 countries
Spain28 sites
Investigational Site Number 724002
Barcelona, 08003
Investigational Site Number 724019
Barcelona, 08035
Investigational Site Number 724012
Barcelona, 08036
Investigational Site Number 724011
Barcelona
Investigational Site Number 724027
Castellon, 12004
Investigational Site Number 724028
Córdoba, 14004
Investigational Site Number 724008
Galdakao (Bilbao), 48960
Investigational Site Number 724010
León, 24071
Investigational Site Number 724001
Lleida
Investigational Site Number 724013
Madrid, 28007
Investigational Site Number 724018
Madrid
Investigational Site Number 724020
Málaga, 29010
Investigational Site Number 724025
Móstoles, 28933
Investigational Site Number 724006
Palma de Mallorca, 07010
Investigational Site Number 724007
Palma de Mallorca, 07010
Investigational Site Number 724024
Pontevedra, 36071
Investigational Site Number 724017
Sabadell, 08208
Investigational Site Number 724022
San Cristóbal de La Laguna - Santa Cruz de Tenerife, 38320
Investigational Site Number 724003
Sant Joan d'Alacant, 3550
Investigational Site Number 724030
Sant Joan Despí, 08970
Investigational Site Number 724023
Santa Cruz de Tenerife, 38010
Investigational Site Number 724014
Santiago de Compostela, 15706
Investigational Site Number 724005
Seville, 41003
Investigational Site Number 724016
Seville, 41010
Investigational Site Number 724004
Seville, 41071
Investigational Site Number 724021
Valencia, 46010
Investigational Site Number 724009
Valladolid, 47011
Investigational Site Number 724029
Vigo, 36200
Italy23 sites
Investigational Site Number 380033
Arzignano (VI), 36071
Investigational Site Number 380016
Catania, 95122
Investigational Site Number 380004
Catania
Investigational Site Number 380006
Catanzaro
Investigational Site Number 380031
Eboli, 84025
Investigational Site Number 380007
Forlì
Investigational Site Number 380018
Genova, 16132
Investigational Site Number 380020
Iglesias (CI), 09016
Investigational Site Number 380015
Milan, 20132
Investigational Site Number 380001
Milan, 20162
Investigational Site Number 380012
Milan
Investigational Site Number 380011
Orbassano (TO), 10043
Investigational Site Number 380026
Padova
Investigational Site Number 380021
Palermo, 90127
Investigational Site Number 380014
Partinico, 90047
Investigational Site Number 380032
Roma, 00133
Investigational Site Number 380002
Roma, 00161
Investigational Site Number 380023
Roma
Investigational Site Number 380036
San Benedetto del Tronto, 63074
Investigational Site Number 380024
Sarzana
Investigational Site Number 380013
Savigliano (CN), 12038
Investigational Site Number 380017
Sesto S. Giovanni, 20099
Investigational Site Number 380025
Torino, 10128
United Kingdom22 sites
Investigational Site Number 826033
Atherstone, CV91EU
Investigational Site Number 826016
Ayr, KA66DX
Investigational Site Number 826039
Blackburn, BB21AX
Investigational Site Number 826008
Bradford on Avon, BA151DQ
Investigational Site Number 826004
Chertsey, KT160PZ
Investigational Site Number 826038
Cornwall, PL143XA
Investigational Site Number 826031
Coventry, CV22DX
Investigational Site Number 826024
Darlington, DL36HX
Investigational Site Number 826035
Dudley, DY1 2HQ
Investigational Site Number 826017
Glasgow, G213UW
Investigational Site Number 826025
Huntingdon, PE296JN
Investigational Site Number 826002
Liverpool, L97AL
Investigational Site Number 826018
Manchester, M239LT
Investigational Site Number 826019
Manchester, M85RB
Investigational Site Number 826037
Manchester, M86RB
Investigational Site Number 826023
Norwich, nr34dg
Investigational Site Number 826009
Nuneaton, CV107DJ
Investigational Site Number 826021
Plymouth, PL53JB
Investigational Site Number 826006
Portsmouth, PO63LY
Investigational Site Number 826020
Southampton, SO303JB
Investigational Site Number 826013
Taunton, TA15DA
Investigational Site Number 826007
Welwyn Garden City, AL74HQ
France14 sites
Investigational Site Number 250008
Amiens, 80054
Investigational Site Number 250011
Bordeaux, 33000
Investigational Site Number 250009
Caen, 14000
Investigational Site Number 250001
Corbeil-Essonnes, 91100
Investigational Site Number 250005
Eaubonne
Investigational Site Number 250026
La Rochelle, 17019
Investigational Site Number 250020
Montpellier, 34059
Investigational Site Number 250015
Mulhouse
Investigational Site Number 250003
Paris, 75018
Investigational Site Number 250010
Pierre-Bénite, 69310
Investigational Site Number 250014
Pierre-Bénite, 69310
Investigational Site Number 250025
Poitiers, 86021
Investigational Site Number 250002
Valenciennes, 59322
Investigational Site Number 250013
Vandœuvre-lès-Nancy, 54511
Brazil9 sites
Investigational Site Number 076-001
Curitiba, 80810-140
Investigational Site Number 076008
Fortaleza, 60115-282
Investigational Site Number 076004
Fortaleza
Investigational Site Number 076009
Rio de Janeiro, 202110340
Investigational Site Number 076011
São José dos Campos, 12243-280
Investigational Site Number 076006
São Paulo, 01223-001
Investigational Site Number 076-003
São Paulo, 01244-030
Investigational Site Number 076005
São Paulo, 04024-002
Investigational Site Number 076010
Taguatinga, 72155000
Romania8 sites
Investigational Site Number 642008
Arad
Investigational Site Number 642005
Baia Mare
Investigational Site Number 642002
Brasov, 500326
Investigational Site Number 642006
Brasov, 500326
Investigational Site Number 642003
Cluj-Napoca, 400006
Investigational Site Number 642007
Cluj-Napoca, 400006
Investigational Site Number 642004
Târgu Mureş, 540015
Investigational Site Number 642001
Timișoara, 300125
Finland6 sites
Investigational Site Number 246008
Helsinki, 00100
Investigational Site Number 246007
Muurame, 40930
Investigational Site Number 246002
Oulu, 90100
Investigational Site Number 246001
Oulu, 90220
Investigational Site Number 246009
Pori, 28100
Investigational Site Number 246004
Rauma, 26100
Greece4 sites
Investigational Site Number 300002
Athens, 18454
Investigational Site Number 300003
Kalamata
Investigational Site Number 300001
Lamia, 35100
Investigational Site Number 300004
Thessaloniki, 56429
Ireland2 sites
Investigational Site Number 372002
Dublin
Investigational Site Number 372003
Dublin
Switzerland2 sites
Investigational Site Number 756003
Bern, 3010
Investigational Site Number 756002
Sankt Gallen, 9007
About this study
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
Primary Objective:
To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change
Read more
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- insulin glargine (U300), insulin glargine (U100), NPH insulin, insulin detemir, insulin degludec
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargine (U300)Drug
Also called HOE901; Toujeo
Pharmaceutical form: solution
Route of administration: subcutaneous
insulin glargine (U100)Drug
Also called HOE901; Lantus
Pharmaceutical form: solution
Route of administration: subcutaneous
NPH insulinDrug
Also called Humulin NPH
Pharmaceutical form: solution
Route of administration: subcutaneous
insulin detemirDrug
Also called Levemir
Pharmaceutical form: solution
Route of administration: subcutaneous
insulin degludecDrug
Also called Tresiba
Pharmaceutical form: solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Toujeo | Experimental | Toujeo will be administered once daily in addition to non-insulin antidiabetic agents Receives: Drug: insulin glargine (U300) |
| "Standard of care" commercially available basal insulin | Active comparator | 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 Receives: Drug: insulin glargine (U100); Drug: NPH insulin; Drug: insulin detemir; Drug: insulin degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (percentage %)
Measured: Baseline to 6 months
Secondary outcomes (11)
Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
Measured: At Month 6 and Month 12
Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
Measured: At Month 6 and Month 12
Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
Measured: At Month 6 and Month 12
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
Measured: At Month 6 and Month 12
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
Measured: At Month 6 and Month 12
Change in HbA1c (percentage %)
Measured: Baseline, Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Measured: At Month 6 and Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Measured: At Month 6 and maintained at Month 12
Percentage of patients requiring intensification
Measured: At Month 6 and Month 12
Time to intensification
Measured: At Month 6 and Month 12
Change in fasting plasma glucose
Measured: From baseline to Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start21 Dec 2015
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 609 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967211
- Sponsor's protocol ID
- LPS14060
- Other IDs
- 2015-001832-39, U1111-1170-8132, 2015
- Acronym
- REGAIN CONTROL
- Status last verified
- Apr 2022
- First submitted
- 16 Nov 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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.
PubMed 33166419Freemantle 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.
PubMed 31865758
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02967211
- Acronym / sponsor ID
- REGAIN CONTROL / LPS14060
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 609 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2015
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toujeo | Experimental | Drug: insulin glargine (U300)Toujeo will be administered once daily in addition to non-insulin antidiabetic agents |
| "Standard of care" commercially available basal insulin | Active comparator | Drug: insulin glargine (U100), Drug: NPH insulin, Drug: insulin detemir, Drug: insulin degludecLantus, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin glargine (U300)Also: HOE901; ToujeoPharmaceutical form: solution Route of administration: subcutaneous | Drug | Toujeo |
| insulin glargine (U100)Also: HOE901; LantusPharmaceutical form: solution Route of administration: subcutaneous | Drug | "Standard of care" commercially available basal insulin |
| NPH insulinAlso: Humulin NPHPharmaceutical form: solution Route of administration: subcutaneous | Drug | "Standard of care" commercially available basal insulin |
| insulin detemirAlso: LevemirPharmaceutical form: solution Route of administration: subcutaneous | Drug | "Standard of care" commercially available basal insulin |
| insulin degludecAlso: TresibaPharmaceutical form: solution Route of administration: subcutaneous | Drug | "Standard of care" commercially available basal insulin |
Primary outcome
Change in HbA1c (percentage %)
Time frame: Baseline to 6 months
11 secondary outcomes
Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
Time frame: At Month 6 and Month 12
Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
Time frame: At Month 6 and Month 12
Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%, <8.0%)
Time frame: At Month 6 and Month 12
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
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
Change in HbA1c (percentage %)
Time frame: Baseline, Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Time frame: At Month 6 and Month 12
Percentage of patients whose HbA1c decreased at least 0.5%
Time frame: At Month 6 and maintained at Month 12
Percentage of patients requiring intensification
Time frame: At Month 6 and Month 12
Time to intensification
Time frame: At Month 6 and Month 12
Change in fasting plasma glucose
Time frame: From baseline to Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 33166419Semlitsch 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.
- Derived from this study: PubMed 31865758Freemantle 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
118 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin glargine (U300), insulin glargine (U100) and NPH insulin in people with Diabetes Mellitus, Type 2, run by Sanofi at 118 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in Spain, Italy, United Kingdom, France, Brazil and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (percentage %) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967211, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.