LivingGLP1
Study S001225

An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Registration

Registration
NCT01940965
Study type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Phase
PHASE3
Masking
NONE
Status
COMPLETED
Enrollment
294
Start
2013-09
Primary completion
2015-07
Lead sponsor
Sanofi
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:lixisenatide AVE0010; DRUG:biguanide; DRUG:TZD; DRUG:alpha-GI; DRUG:glinide
Results posted
FALSE
Secondary identifiers
OTHER:U1111-1129-8754

Registered primary outcomes

  • Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data [52 weeks]

Linked records (1)

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
R0024986Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open-label, multicenter study.
Seino Y, Journal of diabetes investigation
2018Other trialPMID 28429860DOIcites ClinicalTrials.gov:NCT01940965