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Type 2 Diabetes MellitusPhase 3SENIORNCT02320721

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

A Phase 3 study testing Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100) and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 162 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: Percentage of participants with at least one severe and/or confirmed (by plasma glucose… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100) and Background therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,014 participants
Where
162 sitesin 18 countries
Study dates
Jan 2015to May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
  • Signed informed consent.

Who cannot join

  • HbA1c at screening visit:
  • <7.0% or >10.0% for participants taking basal insulin.
  • <7.5% or >11.0% for insulin-naïve participants.
  • History of type 2 diabetes mellitus for less than 1 year before screening.
  • Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
  • Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
Show all 10Show fewer
  • Chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
  • Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score <24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score <24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
  • Participants who had end-stage renal disease (<15 mL/min/1.73m^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

162 sites in 18 countries.

162 sites in 18 countries

United States64 sites

  • Investigational Site Number 840055

    Arlington, Texas, 76014

  • Investigational Site Number 840005

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840048

    Asheville, North Carolina, 28805

  • Investigational Site Number 840013

    Avon, Indiana, 46123

  • Investigational Site Number 840023

    Avon, Indiana, 46123

  • Investigational Site Number 840067

    Bend, Oregon, 97702

  • Investigational Site Number 840030

    Bradenton, Florida, 34208

  • Investigational Site Number 840060

    Bridgeport, West Virginia, 26330

  • Investigational Site Number 840009

    Charlotte, North Carolina, 28209

  • Investigational Site Number 840002

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840046

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840072

    Cincinnati, Ohio, 45219

  • Investigational Site Number 840057

    Corvallis, Oregon, 97330

  • Investigational Site Number 840001

    Dallas, Texas, 75230

  • Investigational Site Number 840026

    Des Moines, Iowa, 50314

  • Investigational Site Number 840039

    Evansville, Indiana, 47714

  • Investigational Site Number 840022

    Fargo, North Dakota, 58103

  • Investigational Site Number 840045

    Feasterville, Pennsylvania, 19053

  • Investigational Site Number 840025

    Federal Way, Washington, 98003

  • Investigational Site Number 840020

    Flint, Michigan, 48504

  • Investigational Site Number 840019

    Fresno, California, 93720

  • Investigational Site Number 840021

    Fresno, California, 93722

  • Investigational Site Number 840040

    Greenbrae, California, 94904

  • Investigational Site Number 840011

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840047

    Greenville, North Carolina, 27834

  • Investigational Site Number 840059

    Greenville, South Carolina, 29605

  • Investigational Site Number 840015

    Greer, South Carolina, 29651

  • Investigational Site Number 840070

    Huntington Park, California, 90255

  • Investigational Site Number 840024

    Irving, Texas, 75039

  • Investigational Site Number 840034

    Knoxville, Tennessee, 37912

  • Investigational Site Number 840027

    Longmont, Colorado, 80501

  • Investigational Site Number 840064

    Los Angeles, California, 90057

  • Investigational Site Number 840069

    Metairie, Louisiana, 70006

  • Investigational Site Number 840010

    Miami, Florida, 33156

  • Investigational Site Number 840035

    Miami, Florida, 33156

  • Investigational Site Number 840006

    Muncie, Indiana, 47304

  • Investigational Site Number 840037

    Nashua, New Hampshire, 03063

  • Investigational Site Number 840014

    New Port Richey, Florida, 34652

  • Investigational Site Number 840018

    New York, New York, 10001

  • Investigational Site Number 840061

    North Richland Hills, Texas, 76180

  • Investigational Site Number 840031

    Norwalk, California, 90650

  • Investigational Site Number 840065

    Oakland, California, 94612

  • Investigational Site Number 840051

    Ocoee, Florida, 34761

  • Investigational Site Number 840050

    Orange, California, 92868

  • Investigational Site Number 840032

    Overland Park, Kansas, 66209

  • Investigational Site Number 840056

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840004

    Peoria, Illinois, 61602

  • Investigational Site Number 840017

    Pittsburgh, Pennsylvania, 15220

  • Investigational Site Number 840028

    Richmond, Texas, 77469

  • Investigational Site Number 840041

    Roswell, Georgia, 30076

  • Investigational Site Number 840016

    Salisbury, North Carolina, 28144

  • Investigational Site Number 840063

    San Antonio, Texas, 78230

  • Investigational Site Number 840058

    Saraland, Alabama, 36571

  • Investigational Site Number 840036

    Simi Valley, California, 93065

  • Investigational Site Number 840029

    Springfield, Illinois, 62704

  • Investigational Site Number 840038

    St. George, Utah, 84790

  • Investigational Site Number 840007

    St. Petersburg, Florida

  • Investigational Site Number 840053

    Statesboro, Georgia, 30461

  • Investigational Site Number 840003

    Temecula, California, 92591

  • Investigational Site Number 840054

    Wadsworth, Ohio, 44281

  • Investigational Site Number 840062

    Walnut Creek, California, 94598

  • Investigational Site Number 840033

    West Des Moines, Iowa, 50266

  • Investigational Site Number 840012

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840042

    Woodstock, Georgia, 30189

Other trials in United States

Canada10 sites

  • Investigational Site Number 124003

    Brampton, L6S 0C9

  • Investigational Site Number 124005

    Burlington, L7M 4Y1

  • Investigational Site Number 124008

    Chatham, N7L 1C1

  • Investigational Site Number 124010

    Mirabel, J7J 2K8

  • Investigational Site Number 124009

    Montreal, H2X 0A9

  • Investigational Site Number 124006

    Sainte-Foy, G1W4R4

  • Investigational Site Number 124004

    Thornhill, L4J 8L7

  • Investigational Site Number 124002

    Toronto, M4G 3E8

  • Investigational Site Number 124001

    Vancouver, V5Y 3W2

  • Investigational Site Number 124007

    Vancouver, V5Z 1L8

Other trials in Canada

Hungary8 sites

  • Investigational Site Number 348004

    Balatonfüred, 8230

  • Investigational Site Number 348001

    Budapest, 1036

  • Investigational Site Number 348005

    Budapest, 1062

  • Investigational Site Number 348007

    Budapest, 1062

  • Investigational Site Number 348003

    Budapest, 1213

  • Investigational Site Number 348008

    Csongrád, 6640

  • Investigational Site Number 348009

    Debrecen, 4031

  • Investigational Site Number 348002

    Gyula, 5700

Other trials in Hungary

Spain8 sites

  • Investigational Site Number 724008

    A Coruña, 15006

  • Investigational Site Number 724004

    Alzira, 46600

  • Investigational Site Number 724001

    Badalona, 08916

  • Investigational Site Number 724002

    Ferrol, 15405

  • Investigational Site Number 724006

    Málaga, 29010

  • Investigational Site Number 724007

    Quart de Poblet, 46930

  • Investigational Site Number 724003

    Sanlúcar de Barrameda, 11540

  • Investigational Site Number 724005

    Seville, 41071

Other trials in Spain

Japan7 sites

  • Investigational Site Number 392008

    Adachi-Ku

  • Investigational Site Number 392003

    Atsugi-Shi

  • Investigational Site Number 392002

    Kamakura-Shi

  • Investigational Site Number 392010

    Sagamihara-Shi

  • Investigational Site Number 392004

    Sakado-Shi

  • Investigational Site Number 392013

    Sapporo

  • Investigational Site Number 392012

    Sendai

Other trials in Japan

Peru7 sites

  • Investigational Site Number 604004

    Arequipa

  • Investigational Site Number 604007

    Ica, 056

  • Investigational Site Number 604002

    Lima, 27

  • Investigational Site Number 604005

    Lima, Lima 09

  • Investigational Site Number 604001

    Lima, LIMA 14

  • Investigational Site Number 604006

    Lima, Lima 32

  • Investigational Site Number 604003

    Piura, 20001

Other trials in Peru

Romania7 sites

  • Investigational Site Number 642006

    Bacau, 600154

  • Investigational Site Number 642001

    Bucharest, 020042

  • Investigational Site Number 642007

    Constanța, 900675

  • Investigational Site Number 642004

    Oradea, 410159

  • Investigational Site Number 642005

    Sibiu, 550371

  • Investigational Site Number 642002

    Târgu Mureş, 540142

  • Investigational Site Number 642003

    Târgu Mureş, 540142

Other trials in Romania

United Kingdom6 sites

  • Investigational Site Number 826003

    Belfast, BT12 6BA

  • Investigational Site Number 826005

    Belfast, BT16 1RH

  • Investigational Site Number 826001

    Bristol, BS10 5NB

  • Investigational Site Number 826004

    Redhill, RH1 5RH

  • Investigational Site Number 826006

    Rotherham, S60 2UD

  • Investigational Site Number 826002

    Swansea, SA2 8PP

Other trials in United Kingdom

Argentina5 sites

  • Investigational Site Number 032001

    Caba, 1120

  • Investigational Site Number 032002

    Caba, 1405

  • Investigational Site Number 032006

    Capital Federal, 1180

  • Investigational Site Number 032004

    Ciudad Autonoma de Buenos Aire, 1206

  • Investigational Site Number 032003

    Mar del Plata, 7602

Other trials in Argentina

Colombia5 sites

  • Investigational Site Number 170004

    Armenia, 630004

  • Investigational Site Number 170007

    Barranquilla, 80020

  • Investigational Site Number 170001

    Bogotá, 110221

  • Investigational Site Number 170005

    Bogotá, 111311

  • Investigational Site Number 170003

    Manizales, 170004

Other trials in Colombia

Germany5 sites

  • Investigational Site Number 276004

    Dresden, 01307

  • Investigational Site Number 276003

    Essen, 45359

  • Investigational Site Number 276001

    München, 81925

  • Investigational Site Number 276005

    Potsdam, 14469

  • Investigational Site Number 276002

    Saarlouis, 66740

Other trials in Germany

Italy5 sites

  • Investigational Site Number 380004

    Bologna, 40138

  • Investigational Site Number 380005

    Chieti, 66013

  • Investigational Site Number 380003

    Genova, 16132

  • Investigational Site Number 380002

    Milan, 20122

  • Investigational Site Number 380001

    Milan, 20132

Other trials in Italy

Poland5 sites

  • Investigational Site Number 616005

    Lublin, 20-538

  • Investigational Site Number 616004

    Szczecin, 70-506

  • Investigational Site Number 616003

    Warsaw, 02-507

  • Investigational Site Number 616002

    Warsaw, 03-242

  • Investigational Site Number 616001

    Zabrze, 41-800

Other trials in Poland

South Korea5 sites

  • Investigational Site Number 410003

    Seoul, 110-744

  • Investigational Site Number 410005

    Seoul, 110-746

  • Investigational Site Number 410002

    Seoul, 135-710

  • Investigational Site Number 410001

    Seoul, 136-705

  • Investigational Site Number 410004

    Wŏnju, 220-701

Other trials in South Korea

Australia4 sites

  • Investigational Site Number 036002

    Box Hill, 3128

  • Investigational Site Number 036004

    Fitzroy, 3065

  • Investigational Site Number 036001

    Geelong, 3220

  • Investigational Site Number 036003

    Herston, 4029

Other trials in Australia

Mexico4 sites

  • Investigational Site Number 484002

    Aguascalientes, 20230

  • Investigational Site Number 484004

    Cuernavaca, 62250

  • Investigational Site Number 484001

    Guadalajara, 44150

  • Investigational Site Number 484003

    Monterrey, 64460

Other trials in Mexico

Sweden4 sites

  • Investigational Site Number 752002

    Gothenburg, 405 45

  • Investigational Site Number 752004

    Härnösand, 871 82

  • Investigational Site Number 752003

    Rättvik, 79530

  • Investigational Site Number 752001

    Västra Frölunda, 421 44

Other trials in Sweden

France3 sites

  • Investigational Site Number 250004

    Lyon, 69495

  • Investigational Site Number 250006

    Nantes, 44093

  • Investigational Site Number 250005

    Poitiers, 86021

Other trials in France

About this study

Official title: A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

  • Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning
  • Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event
  • Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day
  • HbA1c change
Read the detailed description

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Being tested
Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100), Background therapy
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 (HOE901 - U300)Drug

    Also called Toujeo®

    Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

  • Insulin Glargine (HOE901 - U100)Drug

    Also called Lantus®

    Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

  • Background therapyDrug

    Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Study groups in NCT02320721
Study groupRoleWhat they receive
HOE901-U300ExperimentalHOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Receives: Drug: Insulin Glargine (HOE901 - U300); Drug: Background therapy
LantusActive comparatorLantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Receives: Drug: Insulin Glargine (HOE901 - U100); Drug: Background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c From Baseline to Week 26

    Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.

    Measured: Baseline, Week 26

Secondary outcomes (8)

  1. Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period

    Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).

    Measured: Baseline up to Week 26

  2. Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period

    Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).

    Measured: Baseline up to Week 26

  3. Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period

    Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).

    Measured: Baseline up to Week 26

  4. Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period

    Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.

    Measured: Baseline up to Week 26

  5. Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period

    Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).

    Measured: Baseline up to Week 26

  6. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

    Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.

    Measured: Baseline, Week 26

  7. Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26

    WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).

    Measured: Baseline, Week 26

  8. Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment

    Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.

    Measured: Baseline up to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,014 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02320721
Sponsor's protocol ID
EFC13799
Other IDs
2014-002399-10, U1111-1159-3018, 2014
Acronym
SENIOR
Status last verified
Apr 2020
First submitted
16 Dec 2014
Last updated
21 Apr 2020
Data monitoring committee
No

Publications

  • Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12.

    PubMed 29895556

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100) and Background therapy in people with Type 2 Diabetes Mellitus, run by Sanofi at 162 sites in 18 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 2 inclusion and 10 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Canada, Hungary, Spain, Japan and 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Week 26 (time frame: Baseline, Week 26). 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 NCT02320721, which also lists 1 linked publication.

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 21 Apr 2020.

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