Study S002252

The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study

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

Registration

Registration: NCT01966978
Acronym: SIMPLE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 157
Start: 2014-11
Primary completion: 2017-12
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Diabetes Mellitus, Type 2; Diabetes
Interventions: DRUG:Metformin; DRUG:Detemir; DRUG:Liraglutide; DRUG:Insulin Aspart
Results posted: TRUE

Registered primary outcomes

Mean Change From Randomization in A1c at Week 26 [Baseline and Week 26]

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.

Record	Title	Year	Design	Identifiers	Link basis
R0019591	Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study. Patel S, BMJ open diabetes research & care	2019	Randomized trial	PMID 31803482 DOI	cites ClinicalTrials.gov:NCT01966978; registry reference DERIVED:31803482