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Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy (EDITION AP)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin glargine (U300)
Insulin glargine
Non-insulin antihyperglycemic drugs
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion criteria :

  • Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s).
  • Signed written informed consent.

Exclusion criteria:

  • Age < legal age of adulthood.
  • HbA1c <7.0% (<53 mmol/mol) or >11% (>97 mmol/mol) (at screening).
  • History of type 2 diabetes mellitus for less than 1 year before screening.
  • Less than 6 months before screening with non-insulin antihyperglycemic treatment.
  • Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening.
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit.
  • Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization).
  • Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening.
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 1560039
  • Investigational Site Number 1560001
  • Investigational Site Number 1560017
  • Investigational Site Number 1560003
  • Investigational Site Number 1560033
  • Investigational Site Number 1560016
  • Investigational Site Number 1560049
  • Investigational Site Number 1560006
  • Investigational Site Number 1560004
  • Investigational Site Number 1560036
  • Investigational Site Number 1560043
  • Investigational Site Number 1560014
  • Investigational Site Number 1560042
  • Investigational Site Number 1560024
  • Investigational Site Number 1560046
  • Investigational Site Number 1560025
  • Investigational Site Number 1560019
  • Investigational Site Number 1560027
  • Investigational Site Number 1560038
  • Investigational Site Number 1560045
  • Investigational Site Number 1560002
  • Investigational Site Number 1560012
  • Investigational Site Number 1560047
  • Investigational Site Number 1560021
  • Investigational Site Number 1560018
  • Investigational Site Number 1560048
  • Investigational Site Number 1560005
  • Investigational Site Number 1560020
  • Investigational Site Number 1560013
  • Investigational Site Number 1560031
  • Investigational Site Number 1560023
  • Investigational Site Number 1560044
  • Investigational Site Number 1560009
  • Investigational Site Number 1560034
  • Investigational Site Number 1560010
  • Investigational Site Number 1560026
  • Investigational Site Number 1560011
  • Investigational Site Number 1560030
  • Investigational Site Number 1560041
  • Investigational Site Number 4100003
  • Investigational Site Number 4100005
  • Investigational Site Number 4100010
  • Investigational Site Number 4100012
  • Investigational Site Number 4100008
  • Investigational Site Number 4100001
  • Investigational Site Number 4100009
  • Investigational Site Number 4100004
  • Investigational Site Number 4100006
  • Investigational Site Number 4100007
  • Investigational Site Number 4100002
  • Investigational Site Number 1580001
  • Investigational Site Number 1580004
  • Investigational Site Number 1580003
  • Investigational Site Number 1580002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toujeo - insulin glargine (U300)

Lantus - insulin glargine

Arm Description

Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks

Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline

Secondary Outcome Measures

Percentage (%) of patients with at least one hypoglycemia
Percentage (%) of patients with at least one nocturnal hypoglycemia
Percentage (%) of patients with HbA1c <7.0%
Percentage (%) of patients with HbA1c ≤6.5%
Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)
Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)
Percentage (%) of patients requiring rescue therapy
Change in fasting plasma glucose
Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles
Change of mean 24-hour plasma glucose
Change in variability of plasma glucose profile
Change in daily basal insulin dose

Full Information

First Posted
August 2, 2016
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02855684
Brief Title
Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy
Acronym
EDITION AP
Official Title
6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (undefined)
Primary Completion Date
August 6, 2018 (Actual)
Study Completion Date
August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus. Secondary Objectives: To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). To assess the safety and tolerability of insulin glargine (U300). To assess the development of anti-insulin glargine antibodies (AIA).
Detailed Description
The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment 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
604 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toujeo - insulin glargine (U300)
Arm Type
Experimental
Arm Description
Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Arm Title
Lantus - insulin glargine
Arm Type
Active Comparator
Arm Description
Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (U300)
Other Intervention Name(s)
HOE901; Toujeo
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
HOE901; Lantus
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Non-insulin antihyperglycemic drugs
Other Intervention Name(s)
Non-insulin antihyperglycemic therapy
Intervention Description
Pharmaceutical form: capsule/tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Percentage (%) of patients with at least one hypoglycemia
Time Frame
Baseline, up to 6 months
Title
Percentage (%) of patients with at least one nocturnal hypoglycemia
Time Frame
Baseline, up to 6 months
Title
Percentage (%) of patients with HbA1c <7.0%
Time Frame
6 months
Title
Percentage (%) of patients with HbA1c ≤6.5%
Time Frame
6 months
Title
Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)
Time Frame
6 months
Title
Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)
Time Frame
6 months
Title
Percentage (%) of patients requiring rescue therapy
Time Frame
6 months
Title
Change in fasting plasma glucose
Time Frame
Baseline, 6 months
Title
Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles
Time Frame
Baseline, 6 months
Title
Change of mean 24-hour plasma glucose
Time Frame
Baseline, 6 months
Title
Change in variability of plasma glucose profile
Time Frame
Baseline, 6 months
Title
Change in daily basal insulin dose
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). Signed written informed consent. Exclusion criteria: Age < legal age of adulthood. HbA1c <7.0% (<53 mmol/mol) or >11% (>97 mmol/mol) (at screening). History of type 2 diabetes mellitus for less than 1 year before screening. Less than 6 months before screening with non-insulin antihyperglycemic treatment. Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening. Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit. Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization). Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening. Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. The above information is not intended to contain all considerations relevant to a patient'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 1560039
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number 1560001
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Investigational Site Number 1560017
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Investigational Site Number 1560003
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number 1560033
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number 1560016
City
Changzhou
ZIP/Postal Code
213003
Country
China
Facility Name
Investigational Site Number 1560049
City
Changzhou
ZIP/Postal Code
213003
Country
China
Facility Name
Investigational Site Number 1560006
City
Fuzhou
ZIP/Postal Code
354200
Country
China
Facility Name
Investigational Site Number 1560004
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number 1560036
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number 1560043
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Investigational Site Number 1560014
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Investigational Site Number 1560042
City
Guiyang
ZIP/Postal Code
550004
Country
China
Facility Name
Investigational Site Number 1560024
City
Hangzhou
ZIP/Postal Code
310015
Country
China
Facility Name
Investigational Site Number 1560046
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Investigational Site Number 1560025
City
Hohhot
ZIP/Postal Code
010017
Country
China
Facility Name
Investigational Site Number 1560019
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Investigational Site Number 1560027
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Facility Name
Investigational Site Number 1560038
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number 1560045
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number 1560002
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Investigational Site Number 1560012
City
Nanjing
ZIP/Postal Code
210011
Country
China
Facility Name
Investigational Site Number 1560047
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Investigational Site Number 1560021
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Investigational Site Number 1560018
City
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Investigational Site Number 1560048
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Investigational Site Number 1560005
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Investigational Site Number 1560020
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Investigational Site Number 1560013
City
Siping
ZIP/Postal Code
136000
Country
China
Facility Name
Investigational Site Number 1560031
City
Tangshan
ZIP/Postal Code
063000
Country
China
Facility Name
Investigational Site Number 1560023
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Investigational Site Number 1560044
City
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Investigational Site Number 1560009
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site Number 1560034
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Investigational Site Number 1560010
City
Xuzhou
ZIP/Postal Code
221002
Country
China
Facility Name
Investigational Site Number 1560026
City
Yueyang
ZIP/Postal Code
414000
Country
China
Facility Name
Investigational Site Number 1560011
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Investigational Site Number 1560030
City
Zhenjiang
ZIP/Postal Code
212001
Country
China
Facility Name
Investigational Site Number 1560041
City
Zhuzhou
ZIP/Postal Code
412007
Country
China
Facility Name
Investigational Site Number 4100003
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100005
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100010
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100012
City
Gyeonggi-Do
ZIP/Postal Code
11923
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100008
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100001
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100009
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100004
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100006
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100007
City
Seoul
ZIP/Postal Code
138-878
Country
Korea, Republic of
Facility Name
Investigational Site Number 4100002
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Investigational Site Number 1580001
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Investigational Site Number 1580004
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Investigational Site Number 1580003
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Investigational Site Number 1580002
City
Taipei
ZIP/Postal Code
220
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

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