Study S000792

A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00975286
Acronym: GetGoal-Duo1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 446
Start: 2009-10
Primary completion: 2011-08
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Placebo; DRUG:Insulin glargine; DEVICE:Pen auto-injector; DRUG:Metformin; DRUG:Thiazolidinedione (TZD)
Results posted: TRUE
Secondary identifiers: OTHER:EudraCT : 2008-007335-40

Registered primary outcomes

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [Baseline, Week 24]

Linked records (6)

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
R0020702	Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis. Yao J, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Other trial	PMID 36809495 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference DERIVED:36809495
R0012333	Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Davidson JA, Clinical diabetes and endocrinology	2020	Randomized trial	PMID 31956422 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference DERIVED:31956422
R0009175	Propensity-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	2018	Nonrandomized study	PMID 29974618 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference DERIVED:29974618
R0022245	Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. Charbonnel B, Journal of diabetes and its complications	2014	Systematic review	PMID 25130920 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference DERIVED:25130920
R0016145	Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Riddle MC, Diabetes care	2013	Randomized trial	PMID 23628617 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference DERIVED:23628617
R0026107	Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Riddle MC, Diabetes care	2013	Randomized trial	PMID 23564915 DOI	cites ClinicalTrials.gov:NCT00975286; registry reference RESULT:23564915