A Phase 4 interventional study of Insulin glargine and Glimepiride in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-17.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary objective:
To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 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.
List of Inclusion and Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Drug: Insulin glargine · Drug: Metformin
Drug: Glimepiride · Drug: Metformin
Once daily in the morning
Once daily in the morning
At least 1000 mg/day
ß-cell Function parameter
Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
Time frame: From the signature of the Informed Consent Form (ICF) up to the end of study
Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
Time frame: End of the study
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi