Study S002018

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02749890
Acronym: LIXILAN JP-O1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 321
Start: 2016-05-09
Primary completion: 2018-05
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine/Lixisenatide (HOE901/AVE0010); DRUG:Lixisenatide (AVE0010); DRUG:Oral anti-diabetic drugs
Results posted: FALSE
Secondary identifiers: OTHER:U1111-1176-8357

Registered primary outcomes

Change from baseline in HbA1c [Baseline, 26 weeks]

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
R0012993	Benefits of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide (iGlarLixi) in Japanese people with type 2 diabetes: A subgroup and time-to-control analysis of the LixiLan JP phase 3 trials. Terauchi Y, Diabetes, obesity & metabolism	2020	Other trial	PMID 33404200 DOI	cites ClinicalTrials.gov:NCT02749890
R0015751	Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Watada H, Diabetes care	2020	Randomized trial	PMID 32295808 DOI	cites ClinicalTrials.gov:NCT02749890; registry reference RESULT:32295808