Study S001963

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01632163
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: COMPLETED
Enrollment: 447
Start: 2012-10
Primary completion: 2015-05
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo
Results posted: FALSE
Secondary identifiers: OTHER:U1111-1124-1213

Registered primary outcomes

Change in HbA1c [from baseline to week 24]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0020702	Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Yao J, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 36809495 DOI	cites ClinicalTrials.gov:NCT01632163; registry reference DERIVED:36809495
R0014725	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. Yang W, Diabetes, obesity & metabolism	2018	Randomized trial	PMID 28742225 DOI	cites ClinicalTrials.gov:NCT01632163; registry reference DERIVED:28742225