A Phase 3 interventional study of Insulin glargine new formulation (HOE901) and Insulin glargine (HOE901) in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 31 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-05.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 2 diabetes mellitus.
Secondary Objectives:
To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.
To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
The duration of study will consist of:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 240 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.
o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit;
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
once daily in the evening on-top of oral antihyperglycemic drug (OADs)
Drug: Insulin glargine new formulation (HOE901)
once daily in the evening on-top of OADs
Drug: Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: subcutaneous
Also known as: Lantus
Change from baseline in HbA1c
Time frame: baseline, 6 months
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Time frame: up to 6 months
Change from baseline in FPG
Time frame: baseline, 6 months
Change from baseline in pre-basal insulin injection SMPG
Time frame: baseline, 6 months
Change from baseline in 8-point SMPG profiles
Time frame: baseline, 6 months
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Time frame: baseline, 6 months
Change from baseline in variability of plasma glucose profile
Time frame: baseline, 6 months
Change from baseline in daily basal insulin dose
Time frame: baseline, 6 months
Number of patients with various types of hypoglycemia events
Time frame: up to 6 months
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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