A Phase 4 interventional study of INSULIN GLARGINE (U300) and metformin in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary Objective:
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 112 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.
Insulin glargine (U300) will be administered daily through subcutaneous injection, and thereafter, dose will be titrated weekly (preferably 3-4 days) as needed. Background non-insulin anti-diabetic drugs approved for use in combination with insulin according to local labelling, will be permitted, with the exception of Thiazolidinediones (TZDs), which must be stopped at the time of basal insulin initiation.
Drug: INSULIN GLARGINE (U300) · Drug: metformin · Drug: sulfonylurea · Drug: meglitinides · Drug: thiazolidinediones · Drug: alpha-glucosidase inhibitors · Drug: GLP1 Receptor Agonist · Drug: Dipeptidyl peptidase-IV (DPP-IV) inhibitors · Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors
Pharmaceutical form: pen for injection Route of administration: subcutaneous
Also known as: HOE901
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: pen for injection Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Mean change from baseline in HbA1c
Time frame: Baseline, Week 24
Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL
Time frame: At Weeks 12 and 24
Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL)
Time frame: At Weeks 12 and 24
Duration to reach target pre-breakfast SMBG
Time frame: Baseline, Week 24
Mean change from baseline in HbA1c
Time frame: Baseline, Week 12
Mean change from baseline in SMBG
Time frame: Baseline, Weeks 12, and 24
Mean change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Weeks 12, and 24
Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores
Time frame: Baseline, Week 24
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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