Study S001630

A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

ClinicalTrials.gov record

Registration

Registration: NCT01768559
Acronym: GetGoal-Duo-2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 894
Start: 2013-01
Primary completion: 2014-12
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes
Interventions: DRUG:Lixisenatide (AVE0010); DRUG:Insulin glulisine QD; DRUG:Insulin glulisine TID; DRUG:Insulin Glargine (Mandatory background drug); DRUG:Metformin (Background drug)
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2012-004096-38; OTHER:U1111-1131-4936

Registered primary outcomes

Change in HbA1c From Baseline to Week 26 [Baseline, Week 26]
Change in Body Weight From Baseline to Week 26 [Baseline, Week 26]

Linked records (4)

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
R0048087	Vergleich von iGlarLixi mit einem Basal-Bolusregime bei Patienten mit Typ-2-Diabetes mittels Propensity-Score-Matching (PSM) JJ Meier, Diabetologie und Stoffwechsel	2021	Nonrandomized study	DOI	cites ClinicalTrials.gov:NCT01768559
R0015456	Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Tabák ÁG, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Randomized trial	PMID 31848983 DOI	cites ClinicalTrials.gov:NCT01768559; registry reference DERIVED:31848983
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:NCT01768559; registry reference DERIVED:29974618
R0015548	Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Rosenstock J, Diabetes care	2016	Randomized trial	PMID 27222510 DOI	cites ClinicalTrials.gov:NCT01768559; registry reference RESULT:27222510