Study S002636

A Randomized, Open-label, Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes of Toujeo Compared to Commercially Available Basal Insulins for Initiation of Therapy in Insulin-naive Patients With Uncontrolled Type 2 Diabetes Mellitus

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02451137
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 3304
Start: 2015-06-16
Primary completion: 2018-03-02
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Insulin glargine, 300 U/ml; DRUG:Insulin glargine, 100 U/ml; DRUG:Insulin detemir; DRUG:Background Therapy
Results posted: TRUE
Secondary identifiers: OTHER:U1111-1168-0354

Registered primary outcomes

Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia [Baseline to Month 6]

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
R0027538	Achieve control: a pragmatic clinical trial of insulin glargine 300 U/mL versus other basal insulins in insulin-naïve patients with type 2 diabetes. Oster G, Postgraduate medicine	2016	Randomized trial	PMID 27690710 DOI	cites ClinicalTrials.gov:NCT02451137; registry reference DERIVED:27690710