DRUG
Lixisenatide (AVE0010)
Pharmaceutical form:solution Route of administration: subcutaneous injection
Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
Status
Completed
Phase
Phase 3
Enrollment
447
Locations
51
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Full 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)
Interventions
Treatment arms and agents.
DRUG
Placebo
Pharmaceutical form:solution Route of administration: subcutaneous injection
Timeline
From registration to results.
First posted
Jul 2, 2012
Study start
Oct 2012
Primary completion
May 2015
Study completion
May 2015
Results posted
Not reported
Registry updated
Jun 15, 2015
Outcomes
What the study measures.
Primary outcomes
Change in HbA1c
Time frame · from baseline to week 24
Secondary outcomes
Percentage of patients with HbA1c <7%, =<6.5%
Time frame · at week 24
Change in 2-hour postprandial plasma glucose and plasma glucose excursion
Time frame · from baseline to week 24
Change in fasting plasma glucose
Time frame · from baseline to week 24
Change in 7-point self monitoring plasma glucose profile (average and each point)
Time frame · from baseline to week 24
Change in body weight
Time frame · from baseline to week 24
Change in daily basal insulin dose
Time frame · from baseline to week 24
Number of patients with adverse events
Time frame · 24 weeks
Anti-lixisenatide antibody assessment
Time frame · from baseline to week 24
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
51 registered sites.
China · India · Russia · South Korea. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
PMID 36809495 ↗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 28742225 ↗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.
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