Study S002305

A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02752828
Acronym: LIXILAN JP-O2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 521
Start: 2016-05-23
Primary completion: 2018-03-12
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine/lixisenatide (HOE901/AVE0010); DRUG:Insulin glargine (HOE901); DRUG:Oral anti-diabetic drugs
Results posted: FALSE
Secondary identifiers: OTHER:U1111-1176-8450

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
R0007630	Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial. Terauchi Y, Diabetes, obesity & metabolism	2020	Randomized trial	PMID 32291880 DOI	cites ClinicalTrials.gov:NCT02752828; registry reference RESULT:32291880
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:NCT02752828