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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine (U300); Drug: Insulin glargine; Drug: Non-insulin antihyperglycemic drugs

• Registration Number: NCT02855684
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Study Start: 2016-08-24
• Primary Completion: 2018-08-06
• Study Completion: 2018-08-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	Baseline, 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (54)

Investigational Site Number 1560016; 🇨🇳 Changzhou, China

Investigational Site Number 1560001; 🇨🇳 Beijing, China

Investigational Site Number 1560039; 🇨🇳 Beijing, China

Investigational Site Number 1560031; 🇨🇳 Tangshan, China

Investigational Site Number 4100009; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 1560017; 🇨🇳 Beijing, China

Investigational Site Number 1560046; 🇨🇳 Hefei, China

Investigational Site Number 1560027; 🇨🇳 Lanzhou, China

Investigational Site Number 1560048; 🇨🇳 Shenyang, China

Investigational Site Number 1560010; 🇨🇳 Xuzhou, China

Investigational Site Number 1560012; 🇨🇳 Nanjing, China

Investigational Site Number 1580004; 🇨🇳 Taipei, Taiwan

Investigational Site Number 1580001; 🇨🇳 Taichung, Taiwan

Investigational Site Number 1580003; 🇨🇳 Taipei, Taiwan

Investigational Site Number 1580002; 🇨🇳 Taipei, Taiwan

Investigational Site Number 1560033; 🇨🇳 Changchun, China

Investigational Site Number 1560003; 🇨🇳 Beijing, China

Investigational Site Number 1560049; 🇨🇳 Changzhou, China

Investigational Site Number 1560004; 🇨🇳 Guangzhou, China

Investigational Site Number 1560006; 🇨🇳 Fuzhou, China

Investigational Site Number 1560036; 🇨🇳 Guangzhou, China

Investigational Site Number 1560014; 🇨🇳 Guangzhou, China

Investigational Site Number 1560042; 🇨🇳 Guiyang, China

Investigational Site Number 1560043; 🇨🇳 Guangzhou, China

Investigational Site Number 1560024; 🇨🇳 Hangzhou, China

Investigational Site Number 1560025; 🇨🇳 Hohhot, China

Investigational Site Number 1560019; 🇨🇳 Jinan, China

Investigational Site Number 1560038; 🇨🇳 Nanchang, China

Investigational Site Number 1560045; 🇨🇳 Nanchang, China

Investigational Site Number 1560018; 🇨🇳 Shanghai, China

Investigational Site Number 1560005; 🇨🇳 Shenyang, China

Investigational Site Number 1560047; 🇨🇳 Nanjing, China

Investigational Site Number 1560021; 🇨🇳 Shanghai, China

Investigational Site Number 1560020; 🇨🇳 Shenzhen, China

Investigational Site Number 1560013; 🇨🇳 Siping, China

Investigational Site Number 1560011; 🇨🇳 Zhengzhou, China

Investigational Site Number 1560009; 🇨🇳 Xi'An, China

Investigational Site Number 1560023; 🇨🇳 Tianjin, China

Investigational Site Number 1560044; 🇨🇳 Tianjin, China

Investigational Site Number 1560034; 🇨🇳 Xiamen, China

Investigational Site Number 1560030; 🇨🇳 Zhenjiang, China

Investigational Site Number 1560026; 🇨🇳 Yueyang, China

Investigational Site Number 1560041; 🇨🇳 Zhuzhou, China

Investigational Site Number 4100003; 🇰🇷 Anyang, Korea, Republic of

Investigational Site Number 4100008; 🇰🇷 Seoul, 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 4100002; 🇰🇷 Wonju, Korea, Republic of

Investigational Site Number 4100007; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number 1560002; 🇨🇳 Nanjing, China