A Phase 4 interventional study of INSULIN GLARGINE in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-12.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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:
The total duration of study period per patient is up to 6 months.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 242 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels
Drug: INSULIN GLARGINE
Pharmaceutical form:Solution Route of administration: Subcutaneous
Also known as: HOE901
Change from baseline in HbA1c
Time frame: Baseline, 6 months
- Percentage of patients achieving target of HbA1c <7%
Time frame: 6 months
- Change from baseline in fasting plasma glucose values
Time frame: Baseline, 3 months, and 6 months
- Percentage of patients with hypoglycemic events
Time frame: Baseline, 6 months
- Change from baseline in body weight
Time frame: Baseline, 3 months and 6 months
- Number of patients with adverse events
Time frame: Baseline, 6 months
- Change in dose of insulin glargine
Time frame: 3 months and 6 months
- Change in the titration doses used (if any)
Time frame: 6 months
- Time to reach control
Time frame: 6 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Sanofi