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

Type 2 Diabetes Mellitus Clinical Trial

— Soli-CGM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05114590
• Other study ID #: LPS16990
• Secondary ID: U1111-1261-7399
• Status: Completed
• Phase: Phase 4
• Start date: January 27, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 14, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine/Lixisenatide
Solution for injection in a pre-filled pen by subcutaneous injection

Locations

Country	Name	City	State
United States	Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007	Berlin	New Jersey
United States	Clearview Medical Research LLC-Site Number:8400003	Canyon Country	California
United States	Endocrinology Associates Inc-Site Number:8400011	Columbus	Ohio
United States	University of Texas Southwestern Medical Center-Site Number:8400018	Dallas	Texas
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	Palm Research Center, Inc.-Site Number:8400005	Las Vegas	Nevada
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 of Tennessee Health Science Center-Site Number:8400017	Memphis	Tennessee
United States	Floridian Research Institute-Site Number:8400013	Miami	Florida
United States	Premier Research Associate-Miami-Site Number:8400002	Miami	Florida
United States	Mid Hudson Medical Research PLLC-Site Number:8400014	New Windsor	New York
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	University Clinical Investigators Inc-Site Number:8400020	Tustin	California
United States	San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline to Week 16 in coefficient of variation (CV)		Baseline, Week 16
Secondary	Change from baseline to Week 16 in mean daily blood glucose		Baseline, Week 16
Secondary	Change from baseline to Week 16 in the maximum Post Prandial Glucose exposure in the 4 hours post-breakfast meal		Baseline, Week 16
Secondary	Change from baseline to Week 16 in Time above range (TAR)	TAR defined as > 180mg/dL	Baseline, Week 16
Secondary	Percentage of participants achieving CV <36%		Week 16
Secondary	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
Secondary	Percentage of participants achieving Glucose Management Indicator (GMI)	GMI < 7% and < 9%	Week 16
Secondary	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
Secondary	Change from baseline to Week 16 in Time to reach maximum PPG concentration (Tmax)	After start of the breakfast meal	Baseline, Week 16
Secondary	Percentage of participants who spend <15 minutes/day at a glucose level <54 mg/dL		Week 16
Secondary	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
Secondary	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)
Secondary	Number of participants with adverse events		Baseline up to end of study (Week 18)