Study S002333

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00688701
Acronym: GETGOAL-MONO
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 361
Start: 2008-05
Primary completion: 2009-12
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DEVICE:Pen auto-injector
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT 2007-005887-29

Registered primary outcomes

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [Baseline, Week 12]

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
R0013631	Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2024	Systematic review	PMID 38770818 DOI	cites ClinicalTrials.gov:NCT00688701; registry reference DERIVED:38770818
R0022843	Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Fonseca VA, Diabetes care	2012	Randomized trial	PMID 22432104 DOI	cites ClinicalTrials.gov:NCT00688701; registry reference RESULT:22432104