Type 2 Diabetes Mellitus MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Suliqua
Product Name: Insulin glargine and lixisenatide in fixed ratio combination
Product Code: HOE901/AVE0010
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Propose
Sponsors
sanofi-aventis Private Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with type 2 diabetes mellitus diagnosed at least 3 years before screening visit - Basal insulin treatment for at least 6 months - Metformin with or without another Oral Antihyperglycemic Drug (OAD) both at stable dose for at least 3 months - HbA1c at screening visit =7.5% or =10% 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - BMI =20 or >40 kg/m² - History of Type 1 Diabetes mellitus - Any contraindication that excludes the administration of lixisenatide or insulin glargine - History of discontinuation of a previous treatment with a GLP-1 RA for safety/tolerability reasons or lack of efficacy - Current Glucocorticoid therapy; comorbidity with expected intermittent Glucocorticoid therapy during next 18 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Suliqua® once-daily on glycemic control as evaluated by Continuous Glucose Monitoring (CGM) in participants with T2DM uncontrolled on their previous basal insulin;Secondary Objective: To investigate the effect of Suliqua® on - glycemic variability and postprandial glucose excursions - the achievement of glycemic targets with a low risk of hypoglycemia and side effects - the improvement of treatment satisfaction of participants;Primary end point(s): Change in time in glucose range: Mean change in percentage of time (%) in the target glucose range (TIR: 3,9–10 mmol/L; 70–180 mg/dL) from baseline, as measured by using CGM during the last week of an initial 18-week treatment period with Suliqua®.;Timepoint(s) of evaluation of this end point: Last week of an initial 18-week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Mean % of time in target glucose range of 3.9 to 10 mmol/L (70 to 180 mg/dL), as measured by using CGM during the last week of an initial 18-week treatment period with Suliqua®. 2) Mean change in % of time in the hyperglycemia range target with glucose > 10 mmol/L (> 180 mg/dL) and > 13.9 mmol/L( > 250mg/dL) from baseline to Week 18, as measured by CGM 3) Mean change in glucose SD from baseline to week 18 as measured by CGM 4) Mean change in glucose CV from baseline to week 18 as measured by CGM 5) Mean change in MAGE from baseline to week 18 as measured by CGM 6) Mean change in HbA1C from baseline to week 18 7) % of participants with HbA1C < 7.5%, < 7%,= 6,5% 8) Mean change in FPG from baseline to week 18 9) Mean change in body weight from baseline to week 18 10) Mean change in DTSQ score from baseline to week 18 11) Number of participants with at least one symptomatic hypoglycemic event 12) Number of participants with Adverse Events;Timepoint(s) of evaluation of this end point: All: from Baseline to Week 18, except of 1st and 7th points. 1st: last week of an initial 18-week treatment period 7th: at week 18 | — |
Countries
Czech Republic, Hungary
Contacts
Public ContactClinical Research
Sanofi-Aventis Ltd.
Outcome results
None listed