Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period
HbA1c ≥9-13% during the run-in period
On at least 2 OADs with or without GLP-1 RA with stable doses (for both) for 3 months prior to the screening period
Willing and able to wear the CGM device continuously for 14 days to capture CGM measures at baseline until the next site visit and again towards the end of the treatment period
Willing and able to prick fingers a minimum of 2-4 times per week utilizing sterile lancets provided along with a manual blood glucose meter kit
Willing to discontinue the daily (oral or injectable) or weekly GLP-1 RA or DPP 4i prior to administration of iGlarLixi (Soliqua 100/33)
Willing and able to inject iGlarLixi (Soliqua 100/33) and increase dose as needed to achieve SMPG target
Non-pregnant, non-breastfeeding women utilizing a highly-effective contraceptive method or of non-childbearing potential
You may not be if
Type1 Diabetes mellitus (T1DM) or any other types of diabetes, except T2DM
On meglitinides (eg, nateglinide, repaglinide)
Body mass index (BMI) \>40 kg/m² during the screening period
Any current or previous skin conditions, including (but not limited to) severe psoriasis, burns, eczema, scarring, excessive tattoos, that would inhibit the proper wearing of the CGM device
History of severe nausea and vomiting leading to subsequent discontinuation of GLP-1 RA
Known history or presence of clinically significant pancreatitis or gastroparesis
Participants with an episode of severe hypoglycemia or with hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[for example, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels) diagnosed within the 6 months prior to the screening period
Participants with personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposed to MTC (eg, multiple endocrine neoplasia syndromes)
Significant current (within past 2 months) and/or expected use of medications known to affect glycemia (eg, ≥5 mg/day prednisone)
Use of substances known to interfere with CGM readings, such as aspirin-containing products (\>650 mg/day of salicylic acid) or supplements containing vitamin C (\>1000 mg/day of ascorbic acid) during the 14 days of CGM at either baseline or end of treatment period
Previous treatment with any insulin (except for short term treatment due to intercurrent illness, including gestational diabetes, at the discretion of the investigator)
Had used weight loss drugs (including over the counter and herbal medications) within 12 weeks before the screening visit
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial
Clareo Health | Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
