Clinical trial NCT05114590: Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
Official title: A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]
timeFrame: Baseline (Days -14 to -1) and Week 16
Secondary outcomes:
measure: Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Change From Baseline to Week 16 in Mean Daily Blood Glucose
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Percentage of Participants Who Achieved Coefficient of Variation <36%
timeFrame: Week 16
measure: Change From Baseline to Week 16 in Time in Range Per Time Blocks
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9%
timeFrame: Week 16
measure: Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL
timeFrame: Week 16
measure: Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire
timeFrame: Baseline (Days -14 to -1) and Week 16
measure: Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels
timeFrame: From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events
timeFrame: From the first administration of the study drug (Day 1) up to 3 days after last administration of the study drug (maximum exposure duration: up to 16 weeks)
Other outcomes:
Locations:
city: Canyon Country
country: United States
facility: Clearview Medical Research LLC-Site Number:8400003
state: California
city: Huntington Park
country: United States
facility: National Research Institute - ClinEdge - PPDS-Site Number:8400004
state: California
city: Huntington Park
country: United States
facility: National Research Institute - ClinEdge - PPDS-Site Number:8400009
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute-Site Number:8400008
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001
state: California
city: Tustin
country: United States
facility: University Clinical Investigators Inc-Site Number:8400020
state: California
city: West Hills
country: United States
facility: San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012
state: California
city: Miami
country: United States
facility: Premier Research Associate-Miami-Site Number:8400002
state: Florida
city: Miami
country: United States
facility: Floridian Research Institute-Site Number:8400013
state: Florida
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.-Site Number:8400005
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007
state: New Jersey
city: New Windsor
country: United States
facility: Mid Hudson Medical Research PLLC-Site Number:8400014
state: New York
city: Columbus
country: United States
facility: Endocrinology Associates Inc-Site Number:8400011
state: Ohio
city: Memphis
country: United States
facility: University of Tennessee Health Science Center-Site Number:8400017
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center-Site Number:8400018
state: Texas
city: San Antonio
country: United States
facility: Flourish Research - San Antonio - PPDS-Site Number:8400006
state: Texas
city: Schertz
country: United States
facility: Northeast Clinical Research of San Antonio LLC-Site Number:8400019
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research LLC-Site Number:8400010
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: