Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
NCT ID: NCT05114590
Last Updated: 2025-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2022-01-27
2023-04-14
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iGlarLixi
iGlarLixi (i.e., insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.
Insulin glargine/Lixisenatide
Solution for injection in a pre-filled pen by subcutaneous injection. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.
Interventions
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Insulin glargine/Lixisenatide
Solution for injection in a pre-filled pen by subcutaneous injection. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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LPS16990 Plain Language Results Summary
Other Identifiers
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U1111-1261-7399
Identifier Type: REGISTRY
Identifier Source: secondary_id
LPS16990
Identifier Type: -
Identifier Source: org_study_id
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