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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin Glargine (HOE901 - U300)

Insulin Glargine (HOE901 - U100)

Background therapy

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HOE901-U300

Lantus

Arm Description

HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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

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

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.

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).

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.

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).

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%.

Full Information

NCT ID

NCT02320721

First Posted

December 16, 2014

Last Updated

April 10, 2020

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02320721

Brief Title

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

Acronym

SENIOR

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 ≤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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1014 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HOE901-U300

Arm Type

Experimental

Arm Description

HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Arm Title

Lantus

Arm Type

Active Comparator

Arm Description

Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine (HOE901 - U300)

Other Intervention Name(s)

Toujeo®

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Insulin Glargine (HOE901 - U100)

Other Intervention Name(s)

Lantus®

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Background therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in HbA1c From Baseline to Week 26

Description

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.

Time Frame

Baseline, Week 26

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline up to Week 26

Title

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

Description

Time Frame

Baseline up to Week 26

Title

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

Description

Time Frame

Baseline up to Week 26

Title

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

Description

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

Time Frame

Baseline up to Week 26

Title

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

Description

Time Frame

Baseline up to Week 26

Title

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

Description

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

Time Frame

Baseline, Week 26

Title

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

Description

Time Frame

Baseline, Week 26

Title

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

Description

Time Frame

Baseline up to Week 26

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment

Description

Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).

Time Frame

Baseline up to Week 26

Title

Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment

Description

Time Frame

Baseline up to Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840058

City

Saraland

State/Province

Alabama

ZIP/Postal Code

36571

Country

United States

Facility Name

Investigational Site Number 840019

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840021

City

Fresno

State/Province

California

ZIP/Postal Code

93722

Country

United States

Facility Name

Investigational Site Number 840040

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

Country

United States

Facility Name

Investigational Site Number 840070

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

Investigational Site Number 840064

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 840031

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Investigational Site Number 840065

City

Oakland

State/Province

California

ZIP/Postal Code

94612

Country

United States

Facility Name

Investigational Site Number 840050

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Investigational Site Number 840036

City

Simi Valley

State/Province

California

ZIP/Postal Code

93065

Country

United States

Facility Name

Investigational Site Number 840003

City

Temecula

State/Province

California

ZIP/Postal Code

92591

Country

United States

Facility Name

Investigational Site Number 840062

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Investigational Site Number 840027

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

Investigational Site Number 840030

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Investigational Site Number 840010

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Investigational Site Number 840035

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

Facility Name

Investigational Site Number 840014

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 840051

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Investigational Site Number 840056

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840007

City

Saint Petersburg

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840041

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Investigational Site Number 840053

City

Statesboro

State/Province

Georgia

ZIP/Postal Code

30461

Country

United States

Facility Name

Investigational Site Number 840042

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

Investigational Site Number 840005

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Investigational Site Number 840004

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Investigational Site Number 840029

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Investigational Site Number 840013

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840023

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Investigational Site Number 840039

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840006

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47304

Country

United States

Facility Name

Investigational Site Number 840026

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Investigational Site Number 840033

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Investigational Site Number 840032

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66209

Country

United States

Facility Name

Investigational Site Number 840069

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Investigational Site Number 840020

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Investigational Site Number 840037

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03063

Country

United States

Facility Name

Investigational Site Number 840018

City

New York

State/Province

New York

ZIP/Postal Code

10001

Country

United States

Facility Name

Investigational Site Number 840048

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28805

Country

United States

Facility Name

Investigational Site Number 840009

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Investigational Site Number 840011

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Investigational Site Number 840047

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Investigational Site Number 840016

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Investigational Site Number 840012

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Investigational Site Number 840022

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Investigational Site Number 840072

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Investigational Site Number 840054

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

Investigational Site Number 840067

City

Bend

State/Province

Oregon

ZIP/Postal Code

97702

Country

United States

Facility Name

Investigational Site Number 840057

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Investigational Site Number 840045

City

Feasterville

State/Province

Pennsylvania

ZIP/Postal Code

19053

Country

United States

Facility Name

Investigational Site Number 840017

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15220

Country

United States

Facility Name

Investigational Site Number 840059

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Investigational Site Number 840015

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Investigational Site Number 840002

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 840046

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 840034

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37912

Country

United States

Facility Name

Investigational Site Number 840055

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

Investigational Site Number 840001

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Investigational Site Number 840024

City

Irving

State/Province

Texas

ZIP/Postal Code

75039

Country

United States

Facility Name

Investigational Site Number 840061

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Investigational Site Number 840028

City

Richmond

State/Province

Texas

ZIP/Postal Code

77469

Country

United States

Facility Name

Investigational Site Number 840063

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78230

Country

United States

Facility Name

Investigational Site Number 840038

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Investigational Site Number 840025

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Investigational Site Number 840060

City

Bridgeport

State/Province

West Virginia

ZIP/Postal Code

26330

Country

United States

Facility Name

Investigational Site Number 032001

City

Caba

ZIP/Postal Code

1120

Country

Argentina

Facility Name

Investigational Site Number 032002

City

Caba

ZIP/Postal Code

1405

Country

Argentina

Facility Name

Investigational Site Number 032006

City

Capital Federal

ZIP/Postal Code

1180

Country

Argentina

Facility Name

Investigational Site Number 032004

City

Ciudad Autonoma De Buenos Aire

ZIP/Postal Code

1206

Country

Argentina

Facility Name

Investigational Site Number 032003

City

Mar Del Plata

ZIP/Postal Code

7602

Country

Argentina

Facility Name

Investigational Site Number 036002

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Investigational Site Number 036004

City

Fitzroy

ZIP/Postal Code

3065

Country

Australia

Facility Name

Investigational Site Number 036001

City

Geelong

ZIP/Postal Code

3220

Country

Australia

Facility Name

Investigational Site Number 036003

City

Herston

ZIP/Postal Code

4029

Country

Australia

Facility Name

Investigational Site Number 124003

City

Brampton

ZIP/Postal Code

L6S 0C9

Country

Canada

Facility Name

Investigational Site Number 124005

City

Burlington

ZIP/Postal Code

L7M 4Y1

Country

Canada

Facility Name

Investigational Site Number 124008

City

Chatham

ZIP/Postal Code

N7L 1C1

Country

Canada

Facility Name

Investigational Site Number 124010

City

Mirabel

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Investigational Site Number 124009

City

Montreal

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Investigational Site Number 124006

City

Sainte-Foy

ZIP/Postal Code

G1W4R4

Country

Canada

Facility Name

Investigational Site Number 124004

City

Thornhill

ZIP/Postal Code

L4J 8L7

Country

Canada

Facility Name

Investigational Site Number 124002

City

Toronto

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Investigational Site Number 124001

City

Vancouver

ZIP/Postal Code

V5Y 3W2

Country

Canada

Facility Name

Investigational Site Number 124007

City

Vancouver

ZIP/Postal Code

V5Z 1L8

Country

Canada

Facility Name

Investigational Site Number 170004

City

Armenia

ZIP/Postal Code

630004

Country

Colombia

Facility Name

Investigational Site Number 170007

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

Investigational Site Number 170001

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Investigational Site Number 170005

City

Bogota

ZIP/Postal Code

111311

Country

Colombia

Facility Name

Investigational Site Number 170003

City

Manizales

ZIP/Postal Code

170004

Country

Colombia

Facility Name

Investigational Site Number 250004

City

Lyon

ZIP/Postal Code

69495

Country

France

Facility Name

Investigational Site Number 250006

City

Nantes Cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250005

City

Poitiers Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Investigational Site Number 276004

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Investigational Site Number 276003

City

Essen

ZIP/Postal Code

45359

Country

Germany

Facility Name

Investigational Site Number 276001

City

München

ZIP/Postal Code

81925

Country

Germany

Facility Name

Investigational Site Number 276005

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Investigational Site Number 276002

City

Saarlouis

ZIP/Postal Code

66740

Country

Germany

Facility Name

Investigational Site Number 348004

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 348001

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348005

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Investigational Site Number 348007

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Budapest

ZIP/Postal Code

1213

Country

Hungary

Facility Name

Investigational Site Number 348008

City

Csongrád

ZIP/Postal Code

6640

Country

Hungary

Facility Name

Investigational Site Number 348009

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Investigational Site Number 348002

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Investigational Site Number 380004

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Investigational Site Number 380005

City

Chieti

ZIP/Postal Code

66013

Country

Italy

Facility Name

Investigational Site Number 380003

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Investigational Site Number 380002

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Investigational Site Number 380001

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 392008

City

Adachi-Ku

Country

Japan

Facility Name

Investigational Site Number 392003

City

Atsugi-Shi

Country

Japan

Facility Name

Investigational Site Number 392002

City

Kamakura-Shi

Country

Japan

Facility Name

Investigational Site Number 392010

City

Sagamihara-Shi

Country

Japan

Facility Name

Investigational Site Number 392004

City

Sakado-Shi

Country

Japan

Facility Name

Investigational Site Number 392013

City

Sapporo-Shi

Country

Japan

Facility Name

Investigational Site Number 392012

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 410003

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Investigational Site Number 410005

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

Facility Name

Investigational Site Number 410002

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Wonju

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

Investigational Site Number 484002

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

Investigational Site Number 484001

City

Guadalajara

ZIP/Postal Code

44150

Country

Mexico

Facility Name

Investigational Site Number 484003

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 604004

City

Arequipa

Country

Peru

Facility Name

Investigational Site Number 604007

City

Ica

ZIP/Postal Code

056

Country

Peru

Facility Name

Investigational Site Number 604002

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Investigational Site Number 604005

City

Lima

ZIP/Postal Code

Lima 09

Country

Peru

Facility Name

Investigational Site Number 604001

City

Lima

ZIP/Postal Code

LIMA 14

Country

Peru

Facility Name

Investigational Site Number 604006

City

Lima

ZIP/Postal Code

Lima 32

Country

Peru

Facility Name

Investigational Site Number 604003

City

Piura

ZIP/Postal Code

20001

Country

Peru

Facility Name

Investigational Site Number 616005

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Investigational Site Number 616004

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

Investigational Site Number 616003

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 616002

City

Warszawa

ZIP/Postal Code

03-242

Country

Poland

Facility Name

Investigational Site Number 616001

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Investigational Site Number 642006

City

Bacau

ZIP/Postal Code

600154

Country

Romania

Facility Name

Investigational Site Number 642001

City

Bucuresti

ZIP/Postal Code

020042

Country

Romania

Facility Name

Investigational Site Number 642007

City

Constanta

ZIP/Postal Code

900675

Country

Romania

Facility Name

Investigational Site Number 642004

City

Oradea

ZIP/Postal Code

410159

Country

Romania

Facility Name

Investigational Site Number 642005

City

Sibiu

ZIP/Postal Code

550371

Country

Romania

Facility Name

Investigational Site Number 642002

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 642003

City

Targu Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 724004

City

Alzira

ZIP/Postal Code

46600

Country

Spain

Facility Name

Investigational Site Number 724001

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Investigational Site Number 724002

City

El Ferrol

ZIP/Postal Code

15405

Country

Spain

Facility Name

Investigational Site Number 724008

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724006

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724007

City

Quart De Poblet

ZIP/Postal Code

46930

Country

Spain

Facility Name

Investigational Site Number 724003

City

Sanlúcar De Barrameda

ZIP/Postal Code

11540

Country

Spain

Facility Name

Investigational Site Number 724005

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 752002

City

Göteborg

ZIP/Postal Code

405 45

Country

Sweden

Facility Name

Investigational Site Number 752004

City

Härnösand

ZIP/Postal Code

871 82

Country

Sweden

Facility Name

Investigational Site Number 752003

City

Rättvik

ZIP/Postal Code

79530

Country

Sweden

Facility Name

Investigational Site Number 752001

City

Västra Frölunda

ZIP/Postal Code

421 44

Country

Sweden

Facility Name

Investigational Site Number 826003

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Belfast

ZIP/Postal Code

BT16 1RH

Country

United Kingdom

Facility Name

Investigational Site Number 826001

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Investigational Site Number 826004

City

Redhill

ZIP/Postal Code

RH1 5RH

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

Rotherham

ZIP/Postal Code

S60 2UD

Country

United Kingdom

Facility Name

Investigational Site Number 826002

City

Swansea

ZIP/Postal Code

SA2 8PP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29895556

Citation

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. Erratum In: Diabetes Care. 2019 Aug;42(8):1604.

Results Reference

result

Learn more about this trial

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

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

Type 2 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial