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

NCT05114590 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: LPS16990U1111-1261-7399
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 18

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

  The percentage of time spent in the glycemic target range of 70 to 180 mg/dL was calculated as 100 times the number of recorded measurements in the glycemic target range (70 to 180 mg/dL inclusive), divided by the total number of recorded measurements. Baseline is defined as the first 14 evaluable days of evaluable continuous glucose monitoring (CGM) data prior to first day of treatment. CGM compliance is defined as 1) at least 8 out of 14 days (not necessarily consecutive) have 100% of evaluable CGM data per 24-hour period (at least 8 days with 96 records minimum per day) OR 2) at least 9 out of 14 days (not necessarily consecutive) have ≥89% of evaluable CGM data per 24-hour period (at least 9 days with 85 records minimum per day) OR 3) at least 10 out of 14 days (not necessarily consecutive) have at least ≥80% of evaluable CGM data per 24 hour period (at least 10 days with 77 records minimum per day).

  Baseline (Days -14 to -1) and Week 16

Secondary Outcomes (13)

• Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)

  Baseline (Days -14 to -1) and Week 16

• Change From Baseline to Week 16 in Mean Daily Blood Glucose

  Baseline (Days -14 to -1) and Week 16

• Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal

  Baseline (Days -14 to -1) and Week 16

• Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)

  Baseline (Days -14 to -1) and Week 16

• Percentage of Participants Who Achieved Coefficient of Variation <36%

  Week 16

Study Arms (1)

iGlarLixi

EXPERIMENTAL

iGlarLixi (i.e., insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.

Drug: Insulin glargine/Lixisenatide

Interventions

Insulin glargine/Lixisenatide DRUG

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.

Also known as: iGlarLixi, Soliqua 100/33, AVE0010-1

iGlarLixi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (18)

Clearview Medical Research LLC-Site Number:8400003

Canyon Country, California, 91351-4138, United States

Location

National Research Institute - ClinEdge - PPDS-Site Number:8400004

Huntington Park, California, 90255-2959, United States

Location

National Research Institute - ClinEdge - PPDS-Site Number:8400009

Huntington Park, California, 90255-2959, United States

Location

Torrance Clinical Research Institute-Site Number:8400008

Lomita, California, 90717-2101, United States

Location

Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001

Los Angeles, California, 90017-5649, United States

Location

University Clinical Investigators Inc-Site Number:8400020

Tustin, California, 92780, United States

Location

San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012

West Hills, California, 91304-3837, United States

Location

Premier Research Associate-Miami-Site Number:8400002

Miami, Florida, 33165-7043, United States

Location

Floridian Research Institute-Site Number:8400013

Miami, Florida, 33179-2537, United States

Location

Palm Research Center, Inc.-Site Number:8400005

Las Vegas, Nevada, 89128-0463, United States

Location

Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007

Berlin, New Jersey, 08009, United States

Location

Mid Hudson Medical Research PLLC-Site Number:8400014

New Windsor, New York, 12553-7754, United States

Location

Endocrinology Associates Inc-Site Number:8400011

Columbus, Ohio, 43201-3209, United States

Location

University of Tennessee Health Science Center-Site Number:8400017

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center-Site Number:8400018

Dallas, Texas, 75390, United States

Location

Flourish Research - San Antonio - PPDS-Site Number:8400006

San Antonio, Texas, 78229-3539, United States

Location

Northeast Clinical Research of San Antonio LLC-Site Number:8400019

Schertz, Texas, 78154, United States

Location

Consano Clinical Research LLC-Site Number:8400010

Shavano Park, Texas, 78231-1281, United States

Location

Related Links

• LPS16990 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: January 27, 2022
• Primary Completion: March 28, 2023
• Study Completion: April 14, 2023
• Last Updated: September 9, 2025
• Results First Posted: May 24, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (18)