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
NCT ID: NCT02855684
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
604 participants
INTERVENTIONAL
2016-08-24
2018-08-06
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Toujeo - insulin glargine (U300)
Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Insulin glargine (U300)
Pharmaceutical form: solution
Route of administration: subcutaneous
Non-insulin antihyperglycemic drugs
Pharmaceutical form: capsule/tablet
Route of administration: oral
Lantus - insulin glargine
Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
Insulin glargine
Pharmaceutical form: solution
Route of administration: subcutaneous
Non-insulin antihyperglycemic drugs
Pharmaceutical form: capsule/tablet
Route of administration: oral
Interventions
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Insulin glargine (U300)
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin glargine
Pharmaceutical form: solution
Route of administration: subcutaneous
Non-insulin antihyperglycemic drugs
Pharmaceutical form: capsule/tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 1560039
Beijing, , China
Investigational Site Number 1560001
Beijing, , China
Investigational Site Number 1560017
Beijing, , China
Investigational Site Number 1560003
Beijing, , China
Investigational Site Number 1560033
Changchun, , China
Investigational Site Number 1560016
Changzhou, , China
Investigational Site Number 1560049
Changzhou, , China
Investigational Site Number 1560006
Fuzhou, , China
Investigational Site Number 1560004
Guangzhou, , China
Investigational Site Number 1560036
Guangzhou, , China
Investigational Site Number 1560043
Guangzhou, , China
Investigational Site Number 1560014
Guangzhou, , China
Investigational Site Number 1560042
Guiyang, , China
Investigational Site Number 1560024
Hangzhou, , China
Investigational Site Number 1560046
Hefei, , China
Investigational Site Number 1560025
Hohhot, , China
Investigational Site Number 1560019
Jinan, , China
Investigational Site Number 1560027
Lanzhou, , China
Investigational Site Number 1560038
Nanchang, , China
Investigational Site Number 1560045
Nanchang, , China
Investigational Site Number 1560002
Nanjing, , China
Investigational Site Number 1560012
Nanjing, , China
Investigational Site Number 1560047
Nanjing, , China
Investigational Site Number 1560021
Shanghai, , China
Investigational Site Number 1560018
Shanghai, , China
Investigational Site Number 1560048
Shenyang, , China
Investigational Site Number 1560005
Shenyang, , China
Investigational Site Number 1560020
Shenzhen, , China
Investigational Site Number 1560013
Siping, , China
Investigational Site Number 1560031
Tangshan, , China
Investigational Site Number 1560023
Tianjin, , China
Investigational Site Number 1560044
Tianjin, , China
Investigational Site Number 1560009
Xi'an, , China
Investigational Site Number 1560034
Xiamen, , China
Investigational Site Number 1560010
Xuzhou, , China
Investigational Site Number 1560026
Yueyang, , China
Investigational Site Number 1560011
Zhengzhou, , China
Investigational Site Number 1560030
Zhenjiang, , China
Investigational Site Number 1560041
Zhuzhou, , China
Investigational Site Number 4100003
Anyang, , South Korea
Investigational Site Number 4100005
Busan, , South Korea
Investigational Site Number 4100010
Gwangju, , South Korea
Investigational Site Number 4100012
Gyeonggi-do, , South Korea
Investigational Site Number 4100008
Seoul, , South Korea
Investigational Site Number 4100001
Seoul, , South Korea
Investigational Site Number 4100009
Seoul, , South Korea
Investigational Site Number 4100004
Seoul, , South Korea
Investigational Site Number 4100006
Seoul, , South Korea
Investigational Site Number 4100007
Seoul, , South Korea
Investigational Site Number 4100002
Wŏnju, , South Korea
Investigational Site Number 1580001
Taichung, , Taiwan
Investigational Site Number 1580004
Taipei, , Taiwan
Investigational Site Number 1580003
Taipei, , Taiwan
Investigational Site Number 1580002
Taipei, , Taiwan
Countries
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Other Identifiers
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U1111-1139-3894
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12814
Identifier Type: -
Identifier Source: org_study_id
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