Type 1 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
sanofi Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or Female • Age = 18 years • With Type 1 diabetes mellitus • Being treated BID with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year • Have an HbA1c measurement of 8.0% – 10.0% at study entry • Patients who have signed an Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: • Type 2 diabetes mellitus • Known hypoglycaemia unawareness • Repeated episodes of severe hypoglycemia or DKA within the last 12 months • End-stage renal failure or being on hemodialysis • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study • Known hypersensitivity / intolerance to insulin glargine or any of its excipients • Patients treated with GLP-1 receptor agonists • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening • Pregnant or lactating women • Women of childbearing potential with no effective contraceptive method • Participation in another clinical trial • Patient who withdraws consent during the screening or run-in phase (patient who is not willing to continue or fails to return) • Patients who cannot demonstrate the proper use of injection pens, diary or glucose meter before receiving the first injection of Insulin glargine HOE901-300 IU/ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of optimizing treatment from BID basal to OD insulin glargine HOE901-300 IU/mL as part of basal bolus regime in terms of improving HbA1c by at least 0.3% in uncontrolled type 1 diabetes mellitus patients.;Secondary Objective: • To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes and adverse events • To evaluate the effect of Insulin glargine HOE901-300 IU/ml on diabetes treatment satisfaction and fear of hypoglycemia as well as patient’s satisfaction regarding the number of daily injections ;Primary end point(s): Mean HbA1c change ;Timepoint(s) of evaluation of this end point: From baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean HbA1c change from baseline to Week 12 • Mean change in FPG from baseline to Week 12 and Week 24 • Mean change in fasting SMBG from baseline to Week 4, Week 8, Week 12 and Week 24 • Mean change in 8-point SMBG from baseline to Week 12 and Week 24 • Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24 • Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24 without hypoglycemia during the last 4 weeks of treatment • Mean change in body weight from baseline to Week 12 and Week 24 • Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24 • Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented = 70 mg/dL or 3.9 mmol/L) and/or severe hypoglycemia (nocturnal defined as time between 00:00 and 05:59 am) during the last 4 weeks of treatment • Number and proportion of patients experiencing hypoglycemia and number of hypoglycemic events per patient-year during the run-in period, the first 8 weeks of Insulin glargine HOE901-300 IU/ml treatment period, during the whole Insulin glargine HOE901-300 IU/ml treatment period, and during the last 4 weeks of the study. Hypoglycemic events will be recorded o According to definitions (severe, confirmed =70mg/dL and <54mg/dL, and/or severe, confirmed =70mg/dL and <54mg/dL) o And according to the time (nocturnal defined as time between 00.00 and 05:59 am, and at any time of the day) • Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period • Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal define | — |
Countries
Belgium, Canada
Contacts
Public ContactBrigitte De Witte
Sanofi Belgium
Outcome results
None listed