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

NCT02855684 | Completed Phase 3

• 2 other identifiers: EFC12814U1111-1139-3894
• Study Type: interventional
• Target: 604
• Locations: 3 countries
• Sites: 54

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  Baseline, 6 months

Secondary Outcomes (12)

• 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 <7.0%

  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

Study Arms (2)

Toujeo - insulin glargine (U300)

EXPERIMENTAL

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

Drug: Insulin glargine (U300); Drug: Non-insulin antihyperglycemic drugs

Lantus - insulin glargine

ACTIVE COMPARATOR

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

Drug: Insulin glargine; Drug: Non-insulin antihyperglycemic drugs

Interventions

Insulin glargine (U300) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: HOE901; Toujeo

Toujeo - insulin glargine (U300)

Insulin glargine DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: HOE901; Lantus

Lantus - insulin glargine

Non-insulin antihyperglycemic drugs DRUG

Pharmaceutical form: capsule/tablet Route of administration: oral

Also known as: Non-insulin antihyperglycemic therapy

Lantus - insulin glargine; Toujeo - insulin glargine (U300)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (54)

Investigational Site Number 1560039

Beijing, 100034, China

Location

Investigational Site Number 1560001

Beijing, 100044, China

Location

Investigational Site Number 1560017

Beijing, 100191, China

Location

Investigational Site Number 1560003

Beijing, 100730, China

Location

Investigational Site Number 1560033

Changchun, 130021, China

Location

Investigational Site Number 1560016

Changzhou, 213003, China

Location

Investigational Site Number 1560049

Changzhou, 213003, China

Location

Investigational Site Number 1560006

Fuzhou, 354200, China

Location

Investigational Site Number 1560004

Guangzhou, 510080, China

Location

Investigational Site Number 1560036

Guangzhou, 510080, China

Location

Investigational Site Number 1560043

Guangzhou, 510120, China

Location

Investigational Site Number 1560014

Guangzhou, 510515, China

Location

Investigational Site Number 1560042

Guiyang, 550004, China

Location

Investigational Site Number 1560024

Hangzhou, 310015, China

Location

Investigational Site Number 1560046

Hefei, 230001, China

Location

Investigational Site Number 1560025

Hohhot, 010017, China

Location

Investigational Site Number 1560019

Jinan, 250013, China

Location

Investigational Site Number 1560027

Lanzhou, 730000, China

Location

Investigational Site Number 1560038

Nanchang, 330006, China

Location

Investigational Site Number 1560045

Nanchang, 330006, China

Location

Investigational Site Number 1560002

Nanjing, 210008, China

Location

Investigational Site Number 1560012

Nanjing, 210011, China

Location

Investigational Site Number 1560047

Nanjing, 210029, China

Location

Investigational Site Number 1560021

Shanghai, 200040, China

Location

Investigational Site Number 1560018

Shanghai, 200240, China

Location

Investigational Site Number 1560048

Shenyang, 110004, China

Location

Investigational Site Number 1560005

Shenyang, 110022, China

Location

Investigational Site Number 1560020

Shenzhen, 518036, China

Location

Investigational Site Number 1560013

Siping, 136000, China

Location

Investigational Site Number 1560031

Tangshan, 063000, China

Location

Investigational Site Number 1560023

Tianjin, 300052, China

Location

Investigational Site Number 1560044

Tianjin, 300121, China

Location

Investigational Site Number 1560009

Xi'an, 710061, China

Location

Investigational Site Number 1560034

Xiamen, 361003, China

Location

Investigational Site Number 1560010

Xuzhou, 221002, China

Location

Investigational Site Number 1560026

Yueyang, 414000, China

Location

Investigational Site Number 1560011

Zhengzhou, 450052, China

Location

Investigational Site Number 1560030

Zhenjiang, 212001, China

Location

Investigational Site Number 1560041

Zhuzhou, 412007, China

Location

Investigational Site Number 4100003

Anyang, 431-070, South Korea

Location

Investigational Site Number 4100005

Busan, 602-739, South Korea

Location

Investigational Site Number 4100010

Gwangju, 61453, South Korea

Location

Investigational Site Number 4100012

Gyeonggi-do, 11923, South Korea

Location

Investigational Site Number 4100008

Seoul, 01830, South Korea

Location

Investigational Site Number 4100001

Seoul, 03181, South Korea

Location

Investigational Site Number 4100009

Seoul, 06351, South Korea

Location

Investigational Site Number 4100004

Seoul, 110-744, South Korea

Location

Investigational Site Number 4100006

Seoul, 120-752, South Korea

Location

Investigational Site Number 4100007

Seoul, 138-878, South Korea

Location

Investigational Site Number 4100002

Wŏnju, 26426, South Korea

Location

Investigational Site Number 1580001

Taichung, 40447, Taiwan

Location

Investigational Site Number 1580004

Taipei, 104, Taiwan

Location

Investigational Site Number 1580003

Taipei, 11031, Taiwan

Location

Investigational Site Number 1580002

Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: August 24, 2016
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (11); CN (39); TW (4)