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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855684
• Other study ID #: EFC12814
• Secondary ID: U1111-1139-3894
• Status: Completed
• Phase: Phase 3
• Start date: August 24, 2016
• Est. completion date: August 6, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Investigational Site Number 1560001	Beijing
China	Investigational Site Number 1560003	Beijing
China	Investigational Site Number 1560017	Beijing
China	Investigational Site Number 1560039	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 1560014	Guangzhou
China	Investigational Site Number 1560036	Guangzhou
China	Investigational Site Number 1560043	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 1560018	Shanghai
China	Investigational Site Number 1560021	Shanghai
China	Investigational Site Number 1560005	Shenyang
China	Investigational Site Number 1560048	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
Korea, Republic of	Investigational Site Number 4100003	Anyang
Korea, Republic of	Investigational Site Number 4100005	Busan
Korea, Republic of	Investigational Site Number 4100010	Gwangju
Korea, Republic of	Investigational Site Number 4100012	Gyeonggi-Do
Korea, Republic of	Investigational Site Number 4100001	Seoul
Korea, Republic of	Investigational Site Number 4100004	Seoul
Korea, Republic of	Investigational Site Number 4100006	Seoul
Korea, Republic of	Investigational Site Number 4100007	Seoul
Korea, Republic of	Investigational Site Number 4100008	Seoul
Korea, Republic of	Investigational Site Number 4100009	Seoul
Korea, Republic of	Investigational Site Number 4100002	Wonju
Taiwan	Investigational Site Number 1580001	Taichung
Taiwan	Investigational Site Number 1580002	Taipei
Taiwan	Investigational Site Number 1580003	Taipei
Taiwan	Investigational Site Number 1580004	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		Baseline, 6 months
Secondary	Percentage (%) of patients with at least one hypoglycemia		Baseline, up to 6 months
Secondary	Percentage (%) of patients with at least one nocturnal hypoglycemia		Baseline, up to 6 months
Secondary	Percentage (%) of patients with HbA1c <7.0%		6 months
Secondary	Percentage (%) of patients with HbA1c =6.5%		6 months
Secondary	Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L)		6 months
Secondary	Percentage (%) of patients with FPG =120 mg/dL (6.7 mmol/L)		6 months
Secondary	Percentage (%) of patients requiring rescue therapy		6 months
Secondary	Change in fasting plasma glucose		Baseline, 6 months
Secondary	Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles		Baseline, 6 months
Secondary	Change of mean 24-hour plasma glucose		Baseline, 6 months
Secondary	Change in variability of plasma glucose profile		Baseline, 6 months
Secondary	Change in daily basal insulin dose		Baseline, 6 months