Study S001247

A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02750410
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: DOUBLE
Status: COMPLETED
Enrollment: 159
Start: 2016-08
Primary completion: 2018-06-18
Lead sponsor: Eli Lilly and Company
Conditions: Type 2 Diabetes
Interventions: DRUG:Dulaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H9X-JE-GBGF

Registered primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 16]

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
R0023021	Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Ishii H, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Randomized trial	PMID 31758520 DOI	cites ClinicalTrials.gov:NCT02750410; registry reference DERIVED:31758520
R0023153	Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Onishi Y, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Randomized trial	PMID 31994009 DOI	cites ClinicalTrials.gov:NCT02750410; registry reference DERIVED:31994009