drugset / Trial / NCT02606357

Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan

NCT02606357 ↗

Phase 4 Completed 242 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine). Secondary Objectives: * To evaluate the percentage of patients achieving target of HbA1c ˂7%. * To evaluate the change in fasting plasma glucose (FPG). * To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety. * Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.

Timeline

Start
2015-11-22
Primary completion
2017-11-27
Completion
2017-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic — Subcutaneous