Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

Completed · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of the study was to demonstrate if iGlarLixi (Soliqua 100/33) would improve glycemic control (as measured by Time in Range) and glycemic variability in participants with very uncontrolled (HbA1c ≥ 9%) type 2 Diabetes Mellitus (T2DM) while on at least 2 oral antidiabetic drugs \[OADs\] with or without a glucagon-like peptide 1 receptor agonist \[GLP1 RA\]), as measured by continuous glucose monitoring (CGM). The total study duration per participant was approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts were scheduled. * A screening period of up to 2 weeks * A run-in period of up to 2 weeks, including the baseline period * A 16-week, open-label treatment period * A 2-week post-treatment safety follow-up period

Key facts

Study ID: NCT05114590
Run by: Sanofi
People needed: 124
Starts: 2022-01-27
Expected to finish: 2023-04-14
Last updated by the study team: 2025-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

Clearview Medical Research LLC-Site Number:8400003 — Canyon Country, California, United States
National Research Institute - ClinEdge - PPDS-Site Number:8400004 — Huntington Park, California, United States
National Research Institute - ClinEdge - PPDS-Site Number:8400009 — Huntington Park, California, United States
Torrance Clinical Research Institute-Site Number:8400008 — Lomita, California, United States
Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001 — Los Angeles, California, United States
University Clinical Investigators Inc-Site Number:8400020 — Tustin, California, United States
San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012 — West Hills, California, United States
Premier Research Associate-Miami-Site Number:8400002 — Miami, Florida, United States
Floridian Research Institute-Site Number:8400013 — Miami, Florida, United States
Palm Research Center, Inc.-Site Number:8400005 — Las Vegas, Nevada, United States
Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007 — Berlin, New Jersey, United States
Mid Hudson Medical Research PLLC-Site Number:8400014 — New Windsor, New York, United States
Endocrinology Associates Inc-Site Number:8400011 — Columbus, Ohio, United States
University of Tennessee Health Science Center-Site Number:8400017 — Memphis, Tennessee, United States
University of Texas Southwestern Medical Center-Site Number:8400018 — Dallas, Texas, United States
Flourish Research - San Antonio - PPDS-Site Number:8400006 — San Antonio, Texas, United States
Northeast Clinical Research of San Antonio LLC-Site Number:8400019 — Schertz, Texas, United States
Consano Clinical Research LLC-Site Number:8400010 — Shavano Park, Texas, United States

Full record on ClinicalTrials.gov

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