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Clinical Trial Details

Trial ID: L3435
Source ID: NCT01335763
Associated Drug: Insulin Glargine
Title: Pharmacist Intervention for Glycemic Control in The Community
Acronym: RxING
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Insulin glargine
Outcome Measures: Primary: The change in HbA1c from baseline to week 26, The change of the patients' HbA1c between the baseline and the 26 week visits, 6 months | Secondary: Quality of life and patient satisfaction., Quality of life and patient satisfaction is going to be measured through using the questionnaires Audit of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Treatment Satisfaction Questionnaire and Diabetes Treatment Satisfaction Questionnaire change (DTSQ and DTSQc), 6 months|Proportion of patients achieving the target HbA1c, Proportion of patients achieving HbA1c of ≤7.0% during follow-up, 6 months|Type and degree of dosage changes in oral hypoglycemic agents, The type and the degree of changes in the oral hypoglycemic dosing regimen, 6 months|Persistence on insulin glargine, Percentage of patients still taking insulin at the end of follow-up, 6 months|Safety, Number of hypoglycemic episodes; symptomatic confirmed and severe (i.e., Requiring the help from a third party), as defined by the CDA guidelines, 6 months|Health economic evaluation, Cost-effectiveness analyses from a healthcare payor (government) perspective. Costs will include pharmacist training, time spent with patients, pharmaceutical care processes (includes number of face-to-face meetings, time spent with the patient, number and duration of phone calls, number and type of testing per patient, equipment and testing costs, medication costs and out of pocket costs for patients). Clinical benefits will be estimated by modeling the A1C reduction with clinical trials estimates of event reductions, 6 months
Sponsor/Collaborators: Sponsor: University of Alberta | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-04
Completion Date: 2012-10
Results First Posted:
Last Update Posted: 2013-11-06
Locations: EPICORE Centre, Edmonton, Alberta, T6G 2C8, Canada
URL: https://clinicaltrials.gov/show/NCT01335763