LivingGLP1
Study S000646

International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan

ClinicalTrials.gov record

Registration

Registration
NCT02941367
Acronym
LixiRam
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE4
Masking
NONE
Status
COMPLETED
Enrollment
184
Start
2017-02-23
Primary completion
2017-08-04
Lead sponsor
Sanofi
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG:Lixisenatide (AVE0010); DRUG:Sulfonylurea; DRUG:metformin; DRUG:basal insulin
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1172-3026

Registered primary outcomes

  • Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L) [Approximately 30 days (from start to end of Ramadan holy month)]

Linked records (3)

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
R0023732Interventions for people with type 2 diabetes mellitus fasting during Ramadan.
Lee SWH, The Cochrane database of systematic reviews
2023Systematic reviewPMID 37435938DOIcites ClinicalTrials.gov:NCT02941367; registry reference DERIVED:37435938
R0022945Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial.
Sahay R, Diabetes research and clinical practice
2020Randomized trialPMID 32302665DOIcites ClinicalTrials.gov:NCT02941367; registry reference DERIVED:32302665
R0025869Safety of lixisenatide versus sulfonylurea added to basal insulin treatment in people with type 2 diabetes mellitus who elect to fast during Ramadan (LixiRam): An international, randomized, open-label trial.
Hassanein MM, Diabetes research and clinical practice
2019Randomized trialPMID 30772385DOIcites ClinicalTrials.gov:NCT02941367