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

NCT01632163 | Completed Phase 3 DMC

• 2 other identifiers: EFC12382U1111-1124-1213
• Study Type: interventional
• Target: 447
• Locations: 4 countries
• Sites: 51

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  from baseline to week 24

Secondary Outcomes (8)

• Percentage of patients with HbA1c <7%, =<6.5%

  at week 24

• Change in 2-hour postprandial plasma glucose and plasma glucose excursion

  from baseline to week 24

• Change in fasting plasma glucose

  from baseline to week 24

• Change in 7-point self monitoring plasma glucose profile (average and each point)

  from baseline to week 24

• Change in body weight

  from baseline to week 24

Study Arms (2)

Lixisenatide

EXPERIMENTAL

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

Drug: Lixisenatide (AVE0010)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Lixisenatide

Placebo DRUG

Pharmaceutical form:solution Route of administration: subcutaneous injection

Placebo

Eligibility Criteria

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

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (51)

Investigational Site Number 156001

Beijing, 100029, China

Location

Investigational Site Number 156033

Beijing, 100034, China

Location

Investigational Site Number 156006

Beijing, 100088, China

Location

Investigational Site Number 156005

Beijing, 100700, China

Location

Investigational Site Number 156004

Beijing, 100730, China

Location

Investigational Site Number 156002

Beijing, 100853, China

Location

Investigational Site Number 156016

Changchun, 130041, China

Location

Investigational Site Number 156025

Changsha, 410011, China

Location

Investigational Site Number 156014

Chengdu, 610041, China

Location

Investigational Site Number 156013

Chengdu, 610072, China

Location

Investigational Site Number 156034

Dalian, 116027, China

Location

Investigational Site Number 156035

Fuzhou, 354200, China

Location

Investigational Site Number 156021

Guangzhou, 510515, China

Location

Investigational Site Number 156023

Haikou, 570311, China

Location

Investigational Site Number 156017

Harbin, 150001, China

Location

Investigational Site Number 156026

Jinan, 250012, China

Location

Investigational Site Number 156029

Jinan, 250013, China

Location

Investigational Site Number 156019

Nanjing, 210008, China

Location

Investigational Site Number 156020

Nanjing, 210011, China

Location

Investigational Site Number 156018

Qingdao, 266003, China

Location

Investigational Site Number 156028

Shanghai, 200003, China

Location

Investigational Site Number 156007

Shanghai, 200072, China

Location

Investigational Site Number 156032

Shenyang, 110022, China

Location

Investigational Site Number 156009

Shijiazhuang, 050051, China

Location

Investigational Site Number 156036

Siping, 136000, China

Location

Investigational Site Number 156010

Suzhou, 215004, China

Location

Investigational Site Number 156008

Tianjin, 300052, China

Location

Investigational Site Number 156027

Wuhan, 430030, China

Location

Investigational Site Number 156011

Xi'an, 710032, China

Location

Investigational Site Number 156012

Xi'an, 710061, China

Location

Investigational Site Number 356019

Ahmedabad, 380008, India

Location

Investigational Site Number 356018

Aligarh, 202 002, India

Location

Investigational Site Number 356026

Bangalore, 560092, India

Location

Investigational Site Number 356017

Bhubaneswar, 751005, India

Location

Investigational Site Number 356002

Hyderabad, 500004, India

Location

Investigational Site Number 356024

Hyderabad, 500063, India

Location

Investigational Site Number 356015

Nagpur, 440012, India

Location

Investigational Site Number 356008

Pune, 411001, India

Location

Investigational Site Number 356021

Secunderabad, 500003, India

Location

Investigational Site Number 356023

Visakhapatnam, 530002, India

Location

Investigational Site Number 643007

Kirov, 610014, Russia

Location

Investigational Site Number 643003

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643004

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643005

Saint Petersburg, 195112, Russia

Location

Investigational Site Number 643006

Samara, 443067, Russia

Location

Investigational Site Number 410003

Daegu, 705-703, South Korea

Location

Investigational Site Number 410007

Goyang, 411-706, South Korea

Location

Investigational Site Number 410006

Seoul, 130-872, South Korea

Location

Investigational Site Number 410001

Seoul, 136-705, South Korea

Location

Investigational Site Number 410005

Seoul, 139-872, South Korea

Location

Investigational Site Number 410002

Wŏnju, 220-701, South Korea

Location

Related Publications (2)

• 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.

  PMID: 36809495 DERIVED

• 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.

  PMID: 28742225 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 2, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 15, 2015

Record last verified: 2015-06

Locations

IN (10); RU (5); KR (6); CN (30)