Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

NCT ID: NCT01632163

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-05-31

Brief Summary

Primary Objective:

• To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

• To assess the effects of lixisenatide over 24 weeks on :

• percentage of patients reaching HbA1c<7% or ≤6.5%,
• 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
• fasting plasma glucose (FPG),
• change in 7-point self-monitored plasma glucose (SMPG) profile),
• body weight,
• change in daily basal insulin dose.
• To assess lixisenatide safety and tolerability.
• To assess anti-lixisenatide antibody development.

Detailed Description

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lixisenatide

24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Placebo

24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Interventions

Lixisenatide (AVE0010)

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Intervention Type: DRUG

Placebo

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion Criteria

At screening:

• Age < legal age of adulthood.
• HbA1c<7% or >10.5%.
• Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
• If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
• History of hypoglycemia unawareness.
• Body Mass Index (BMI) ≤20 kg/m².
• Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 156001

Beijing, , China

Investigational Site Number 156033

Beijing, , China

Investigational Site Number 156006

Beijing, , China

Investigational Site Number 156005

Beijing, , China

Investigational Site Number 156004

Beijing, , China

Investigational Site Number 156002

Beijing, , China

Investigational Site Number 156016

Changchun, , China

Investigational Site Number 156025

Changsha, , China

Investigational Site Number 156014

Chengdu, , China

Investigational Site Number 156013

Chengdu, , China

Investigational Site Number 156034

Dalian, , China

Investigational Site Number 156035

Fuzhou, , China

Investigational Site Number 156021

Guangzhou, , China

Investigational Site Number 156023

Haikou, , China

Investigational Site Number 156017

Harbin, , China

Investigational Site Number 156026

Jinan, , China

Investigational Site Number 156029

Jinan, , China

Investigational Site Number 156019

Nanjing, , China

Investigational Site Number 156020

Nanjing, , China

Investigational Site Number 156018

Qingdao, , China

Investigational Site Number 156028

Shanghai, , China

Investigational Site Number 156007

Shanghai, , China

Investigational Site Number 156032

Shenyang, , China

Investigational Site Number 156009

Shijiazhuang, , China

Investigational Site Number 156036

Siping, , China

Investigational Site Number 156010

Suzhou, , China

Investigational Site Number 156008

Tianjin, , China

Investigational Site Number 156027

Wuhan, , China

Investigational Site Number 156011

Xi'an, , China

Investigational Site Number 156012

Xi'an, , China

Investigational Site Number 356019

Ahmedabad, , India

Investigational Site Number 356018

Aligarh, , India

Investigational Site Number 356026

Bangalore, , India

Investigational Site Number 356017

Bhubaneswar, , India

Investigational Site Number 356002

Hyderabad, , India

Investigational Site Number 356024

Hyderabad, , India

Investigational Site Number 356015

Nagpur, , India

Investigational Site Number 356008

Pune, , India

Investigational Site Number 356021

Secunderabad, , India

Investigational Site Number 356023

Visakhapatnam, , India

Investigational Site Number 643007

Kirov, , Russia

Investigational Site Number 643003

Saint Petersburg, , Russia

Investigational Site Number 643004

Saint Petersburg, , Russia

Investigational Site Number 643005

Saint Petersburg, , Russia

Investigational Site Number 643006

Samara, , Russia

Investigational Site Number 410003

Daegu, , South Korea

Investigational Site Number 410007

Goyang, , South Korea

Investigational Site Number 410006

Seoul, , South Korea

Investigational Site Number 410001

Seoul, , South Korea

Investigational Site Number 410005

Seoul, , South Korea

Investigational Site Number 410002

Wŏnju, , South Korea

Countries

China; India; Russia; South Korea

References

Yao J, Zhang M, Zhang X, Zhang J. Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Diabetes Ther. 2023 Apr;14(4):653-669. doi: 10.1007/s13300-023-01369-6. Epub 2023 Feb 21.

Reference Type: DERIVED

PMID: 36809495 (View on PubMed)

Yang W, Min K, Zhou Z, Li L, Xu X, Zhu D, Venkateshwar Rao A, Murthy LS, Zhang N, Li I, Niemoeller E, Shang S. Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018 Feb;20(2):335-343. doi: 10.1111/dom.13072. Epub 2017 Oct 5.

Reference Type: DERIVED

PMID: 28742225 (View on PubMed)

Other Identifiers

U1111-1124-1213

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12382

Identifier Type: -

Identifier Source: org_study_id