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

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

The purpose of the study is to demonstrate if Soliqua 100/33 improves 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 glucagonlike peptide 1 receptor agonist [GLP1 RA]), as measured by continuous glucose monitoring (CGM).

The total study duration per participant will be approximately 22 weeks. Three site visits, 3 site or home visits, and up to 13 phone contacts are scheduled.

• A screening period of up to 2 weeks
• A run-in period of up to 2 weeks and includes the baseline period
• A 16-week, open-label treatment period
• A 2-week post-treatment safety follow-up period

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin glargine/Lixisenatide

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Canyon Country, California, United States, 91351-4138
      • Clearview Medical Research LLC-Site Number:8400003
    • Huntington Park, California, United States, 90255-2959
      • National Research Institute - ClinEdge - PPDS-Site Number:8400004
    • Huntington Park, California, United States, 90255-2959
      • National Research Institute - ClinEdge - PPDS-Site Number:8400009
    • Lomita, California, United States, 90717-2101
      • Torrance Clinical Research Institute-Site Number:8400008
    • Los Angeles, California, United States, 90017-5649
      • Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001
    • Tustin, California, United States, 92780
      • University Clinical Investigators Inc-Site Number:8400020
    • West Hills, California, United States, 91304-3837
      • San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012
  • Florida
    • Miami, Florida, United States, 33165-7043
      • Premier Research Associate-Miami-Site Number:8400002
    • Miami, Florida, United States, 33179-2537
      • Floridian Research Institute-Site Number:8400013
  • Nevada
    • Las Vegas, Nevada, United States, 89128-0463
      • Palm Research Center, Inc.-Site Number:8400005
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007
  • New York
    • New Windsor, New York, United States, 12553-7754
      • Mid Hudson Medical Research PLLC-Site Number:8400014
  • Ohio
    • Columbus, Ohio, United States, 43201-3209
      • Endocrinology Associates Inc-Site Number:8400011
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center-Site Number:8400017
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center-Site Number:8400018
    • San Antonio, Texas, United States, 78229-3539
      • Flourish Research - San Antonio - PPDS-Site Number:8400006
    • Schertz, Texas, United States, 78154
      • Northeast Clinical Research of San Antonio LLC-Site Number:8400019
    • Shavano Park, Texas, United States, 78231-1281
      • Consano Clinical Research LLC-Site Number:8400010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Soliqua 100/33
• Willing and able to inject Soliqua 100/33 and increase dose as needed to achieve SMPG target
• Non-pregnant, non-breastfeeding women utilizing a high-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 predisposes 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)
• Has used weight loss drugs (including over the counter and herbal medications) within 12 weeks before the screening visit

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soliqua 100/33; Soliqua 100/33 (Insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.	Drug: Insulin glargine/Lixisenatide; Solution for injection in a pre-filled pen by subcutaneous injection; Other Names: Soliqua 100/33; AVE0010-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to week 16 in the percentage of Time in Range (TIR)	TIR defined as 70-180 mg/dL	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Week 16 in coefficient of variation (CV)		Baseline, Week 16
Change from baseline to Week 16 in mean daily blood glucose		Baseline, Week 16
Change from baseline to Week 16 in the maximum Post Prandial Glucose exposure in the 4 hours post-breakfast meal		Baseline, Week 16
Change from baseline to Week 16 in Time above range (TAR)	TAR defined as > 180mg/dL	Baseline, Week 16
Percentage of participants achieving CV <36%		Week 16
Change from baseline to Week 16 in TIR per time blocks	TIR (70-180 mg/dL) for specific time blocks defined as 6 am-12 pm; 12 pm-6 pm; 6 pm-12 am, and 12 am-6 am	Baseline, Week 16
Percentage of participants achieving Glucose Management Indicator (GMI)	GMI < 7% and < 9%	Week 16
Change from baseline to Week 16 in the 4-hour PPG area under the concentration time curve (AUC0-4h)	After start of the breakfast meal	Baseline, Week 16
Change from baseline to Week 16 in Time to reach maximum PPG concentration (Tmax)	After start of the breakfast meal	Baseline, Week 16
Percentage of participants who spend <15 minutes/day at a glucose level <54 mg/dL		Week 16
Change from baseline to Week 16 in diabetes medication treatment satisfaction scores	The Diabetes Medication Satisfaction Tool (DM SAT) questionnaire is a 16-item measure with higher score indicative of better satisfaction	Baseline, Week 16
Number of participants with confirmed hypoglycemia	Including overall hypoglycemia, hypoglycemia with glucose concentration <70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L), <54 mg/dL (3.0 mmol/L) and severe hypoglycemia	Baseline up to end of study (Week 18)
Number of participants with adverse events		Baseline up to end of study (Week 18)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine; Lixisenatide
• Other Study ID Numbers: LPS16990; U1111-1261-7399 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No