LivingGLP1
Study S001199

A Randomized, 30 Week, Active-controlled, Open-label, 3-treatment Arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination to Insulin Glargine Alone and to Lixisenatide Alone on Top of Metformin in Patients With Type 2 Diabetes Mellitus (T2DM)

Registration

Registration
NCT02058147
Acronym
LixiLan-O
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
1170
Start
2014-02
Primary completion
2015-06
Lead sponsor
Sanofi
Conditions
Type 2 Diabetes
Interventions
DRUG:Insulin glargine/lixisenatide Fixed Ratio Combination; DRUG:Insulin glargine (HOE901); DRUG:Lixisenatide (AVE0010); DRUG:Metformin
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2013-003131-30; OTHER:U1111-1148-4334

Registered primary outcomes

  • Change in HbA1c From Baseline to Week 30 [Baseline, Week 30]

Linked records (16)

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.
RecordTitleYearDesignIdentifiersLink basis
R0042144Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin >= 8%, >= 64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial
Melanie J Davies (7258691), Figshare
2023Randomized trialcites ClinicalTrials.gov:NCT02058147
R0013783Efficacy of iGlarLixi in adults with type 2 diabetes inadequately controlled (glycated haemoglobin ≥8%, ≥64 mmol/mol) on two oral antidiabetes drugs: Post hoc analysis of the LixiLan-O randomized trial.
Davies MJ, Diabetes, obesity & metabolism
2022Randomized trialPMID 34617398DOIcites ClinicalTrials.gov:NCT02058147
R0015023Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study.
Shao H, Journal of diabetes and its complications
2022Nonrandomized studyPMID 35101326DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:35101326
R0011584Glycaemic target attainment in people with Type 2 diabetes treated with insulin glargine/lixisenatide fixed-ratio combination: a post hoc analysis of the LixiLan-O and LixiLan-L trials.
Davidson JA, Diabetic medicine : a journal of the British Diabetic Association
2020Other trialPMID 31365765DOIcites ClinicalTrials.gov:NCT02058147
R0007277EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.
Mora PF, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2019Randomized trialPMID 31241362DOIcites ClinicalTrials.gov:NCT02058147
R0012646Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes.
Schmider W, Current medical research and opinion
2019OtherPMID 30550345DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:30550345
R0012665Post hoc efficacy and safety analysis of insulin glargine/lixisenatide fixed- ratio combination in North American patients compared with the rest of world.
Dailey G, BMJ open diabetes research & care
2019Nonrandomized studyPMID 31114694DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:31114694
R0015993Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial.
Davies MJ, Diabetes, obesity & metabolism
2019Randomized trialPMID 31124299DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:31124299
R0009175Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
Rosenstock J, Diabetes, obesity & metabolism
2018Nonrandomized studyPMID 29974618DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:29974618
R0014110Low incidence of gastrointestinal adverse events over time with a fixed-ratio combination of insulin glargine and lixisenatide versus lixisenatide alone.
Trujillo JM, Diabetes, obesity & metabolism
2018Other trialPMID 29923298DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:29923298
R0049204Relationship of Ethnicity to Clinical Outcomes in iGlarLixi-Treated Patients with Type 2 Diabetes
Pablo Mora, Diabetes
2018Other trialDOIcites ClinicalTrials.gov:NCT02058147
R0051252Glycemic Target Attainment in Insulin-Naïve Patients with T2D Receiving iGlarLixi
Cyrus V Desouza, Diabetes
2018Other trialDOIcites ClinicalTrials.gov:NCT02058147
R0012685Impact of baseline glycated haemoglobin, diabetes duration and body mass index on clinical outcomes in the LixiLan-O trial testing a titratable fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine and lixisenatide monocomponents.
Davies MJ, Diabetes, obesity & metabolism
2017Other trialPMID 28432746DOIcites ClinicalTrials.gov:NCT02058147; registry reference DERIVED:28432746
R0044406Low incidence of gastrointestinal adverse events over time with a combination of insulin glargine and lixisenatide
Bowden Georgina
2017Randomized trialDOIcites ClinicalTrials.gov:NCT02058147
R0017964Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial.
Rosenstock J, Diabetes care
2016Randomized trialPMID 27527848DOIcites ClinicalTrials.gov:NCT02058147; registry reference RESULT:27527848
R0045038Clinical Impact of Titratable Fixed-Ratio Combination of Insulin Glargine/Lixisenatide vs. Each Component Alone in Type 2 Diabetes Inadequately Controlled on Oral Agents: LixiLan-O Trial (NCT02058147)
Ronnie Aronson, Canadian Journal of Diabetes
2016Other trialDOIcites ClinicalTrials.gov:NCT02058147