Clinical trial NCT02855684: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Percentage (%) of patients with at least one hypoglycemia
timeFrame: Baseline, up to 6 months
measure: Percentage (%) of patients with at least one nocturnal hypoglycemia
timeFrame: Baseline, up to 6 months
measure: Percentage (%) of patients with HbA1c <7.0%
timeFrame: 6 months
measure: Percentage (%) of patients with HbA1c ≤6.5%
timeFrame: 6 months
measure: Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)
timeFrame: 6 months
measure: Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L)
timeFrame: 6 months
measure: Percentage (%) of patients requiring rescue therapy
timeFrame: 6 months
measure: Change in fasting plasma glucose
timeFrame: Baseline, 6 months
measure: Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles
timeFrame: Baseline, 6 months
measure: Change of mean 24-hour plasma glucose
timeFrame: Baseline, 6 months
measure: Change in variability of plasma glucose profile
timeFrame: Baseline, 6 months
measure: Change in daily basal insulin dose
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560039
city: Beijing
country: China
facility: Investigational Site Number 1560001
city: Beijing
country: China
facility: Investigational Site Number 1560017
city: Beijing
country: China
facility: Investigational Site Number 1560003
city: Changchun
country: China
facility: Investigational Site Number 1560033
city: Changzhou
country: China
facility: Investigational Site Number 1560016
city: Changzhou
country: China
facility: Investigational Site Number 1560049
city: Fuzhou
country: China
facility: Investigational Site Number 1560006
city: Guangzhou
country: China
facility: Investigational Site Number 1560004
city: Guangzhou
country: China
facility: Investigational Site Number 1560036
city: Guangzhou
country: China
facility: Investigational Site Number 1560043
city: Guangzhou
country: China
facility: Investigational Site Number 1560014
city: Guiyang
country: China
facility: Investigational Site Number 1560042
city: Hangzhou
country: China
facility: Investigational Site Number 1560024
city: Hefei
country: China
facility: Investigational Site Number 1560046
city: Hohhot
country: China
facility: Investigational Site Number 1560025
city: Jinan
country: China
facility: Investigational Site Number 1560019
city: Lanzhou
country: China
facility: Investigational Site Number 1560027
city: Nanchang
country: China
facility: Investigational Site Number 1560038
city: Nanchang
country: China
facility: Investigational Site Number 1560045
city: Nanjing
country: China
facility: Investigational Site Number 1560002
city: Nanjing
country: China
facility: Investigational Site Number 1560012
city: Nanjing
country: China
facility: Investigational Site Number 1560047
city: Shanghai
country: China
facility: Investigational Site Number 1560021
city: Shanghai
country: China
facility: Investigational Site Number 1560018
city: Shenyang
country: China
facility: Investigational Site Number 1560048
city: Shenyang
country: China
facility: Investigational Site Number 1560005
city: Shenzhen
country: China
facility: Investigational Site Number 1560020
city: Siping
country: China
facility: Investigational Site Number 1560013
city: Tangshan
country: China
facility: Investigational Site Number 1560031
city: Tianjin
country: China
facility: Investigational Site Number 1560023
city: Tianjin
country: China
facility: Investigational Site Number 1560044
city: Xi'An
country: China
facility: Investigational Site Number 1560009
city: Xiamen
country: China
facility: Investigational Site Number 1560034
city: Xuzhou
country: China
facility: Investigational Site Number 1560010
city: Yueyang
country: China
facility: Investigational Site Number 1560026
city: Zhengzhou
country: China
facility: Investigational Site Number 1560011
city: Zhenjiang
country: China
facility: Investigational Site Number 1560030
city: Zhuzhou
country: China
facility: Investigational Site Number 1560041
city: Anyang
country: Korea, Republic of
facility: Investigational Site Number 4100003
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 4100005
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 4100010
city: Gyeonggi-Do
country: Korea, Republic of
facility: Investigational Site Number 4100012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100009
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4100007
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number 4100002
city: Taichung
country: Taiwan
facility: Investigational Site Number 1580001
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580004
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580003
city: Taipei
country: Taiwan
facility: Investigational Site Number 1580002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: