Trial Outcomes & Findings for 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 NCT05114590)

NCT ID: NCT05114590

Last Updated: 2025-09-09

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 124 participants
• Primary outcome timeframe: Baseline (Days -14 to -1) and Week 16
• Results posted on: 2025-09-09

Participant Flow

The study was conducted at 17 centers in the United States. A total of 244 participants were screened between 27 January 2022 and 03 December 2022, of which 120 were screen failures. Screen failures were mainly due to not meeting glycated hemoglobin inclusion criteria.

A total of 124 participants were enrolled in the study.

Participant milestones

Measure	iGlarLixi Participants received iGlarLixi (Soliqua 100/33) subcutaneous injection once daily for 16 weeks.
Overall Study STARTED	124
Overall Study Completed the 16-week Study Treatment Period	111
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	iGlarLixi Participants received iGlarLixi (Soliqua 100/33) subcutaneous injection once daily for 16 weeks.
Overall Study Adverse Event	1
Overall Study Investigator decision	1
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	5
Overall Study Other	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	iGlarLixi n=124 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Age, Continuous	55.6 years STANDARD_DEVIATION 11.08 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Black	21 Participants n=5 Participants
Race/Ethnicity, Customized White	89 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants

PRIMARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

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).

Outcome measures

Measure	iGlarLixi n=113 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]	26.22 percentage of time Interval 20.5 to 31.9

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

Glucose total CV was calculated by following: standard deviation glucose/mean glucose over 14 days x 100, and the percent change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Outcome measures

Measure	iGlarLixi n=113 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV)	5.0 percent change Interval 3.8 to 6.1

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

A global average was computed to determine the average of the mean daily blood glucose for the 14 days at baseline and Week 16. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Outcome measures

Measure	iGlarLixi n=113 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in Mean Daily Blood Glucose	-52.48 mg/dL Interval -64.6 to -40.3

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

The analysis was focused on the 4-hour interval at both baseline and Week 16 from t=0 (the timepoint at which glucose measurement was taken immediately preceding liquid meal administration) throughout the subsequent 4 hours. For each participant, the overall maximum glucose value within the described 4-hour period was determined, and the difference between the maximum glucose value at baseline and Week 16 was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Outcome measures

Measure	iGlarLixi n=118 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal	-73.66 mg/dL Interval -90.9 to -56.4

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

The time spent above the glycemic target range was calculated as 100 times the total number of 15-minute increments of CGM data where a participant's blood glucose falls above normal range (>180 mg/dL) at baseline, divided by the total number of 15-minute increments read (i.e., up to 1344 15-minute increments) at Week 16. This was calculated for baseline and Week 16 and the change was reported. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Outcome measures

Measure	iGlarLixi n=113 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)	-28.67 percentage of time Interval -34.6 to -22.7

SECONDARY outcome

Timeframe: Week 16

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at Week 16 are reported.

Percentage of participants achieving CV <36% was calculated as sum of the number of participants with CV <36% divided by the total number of participants. The endpoint was calculated using all CGM glucose readings available throughout each day for 2 weeks (Week 14-16).

Outcome measures

Measure	iGlarLixi n=100 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Percentage of Participants Who Achieved Coefficient of Variation <36%	76.0 percentage of participants Interval 66.4 to 84.0

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

Time spent in the glycemic target range (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 per time block and comparing the corresponding time blocks from Week 16 to baseline. The time blocks are 12 am to 6 am, 6 am to 12 pm, 12 pm to 6 pm, 6 pm to 12 am, and 6 am to 12 am. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of treatment.

Outcome measures

Measure	iGlarLixi n=100 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in Time in Range Per Time Blocks 12 pm to 6 pm	31.05 percentage of time Interval 24.5 to 37.6
Change From Baseline to Week 16 in Time in Range Per Time Blocks 6 pm to 12 am	25.87 percentage of time Interval 19.8 to 31.9
Change From Baseline to Week 16 in Time in Range Per Time Blocks 6 am to 12 am	30.21 percentage of time Interval 24.1 to 36.3
Change From Baseline to Week 16 in Time in Range Per Time Blocks 12 am to 6 am	27.89 percentage of time Interval 21.3 to 34.5
Change From Baseline to Week 16 in Time in Range Per Time Blocks 6 am to 12 pm	33.73 percentage of time Interval 27.0 to 40.5

SECONDARY outcome

Timeframe: Week 16

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants with GMI data available at Week 16 are reported.

The GMI was calculated as 3.31 + 0.02392 x (mean glucose in mg/dL from CGM data). The GMI was calculated by determining the number of participants who achieved <7% and <9% at Week 16.

Outcome measures

Measure	iGlarLixi n=100 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9% GMI <7%	43.0 percentage of participants Interval 33.1 to 53.3
Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9% GMI <9%	85.0 percentage of participants Interval 76.5 to 91.4

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

Blood samples were collected to measure the glucose values up to 4-hour after the breakfast meal. The analysis was based on a liquid meal at both baseline and Week 16 (a liquid meal administered in a fasted state and blood glucose is measured at specific time points up to 4 hours). Baseline is defined as the time period prior to administration of study drug.

Outcome measures

Measure	iGlarLixi n=102 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in the 4-Hour Postprandial Glucose Area Under the Concentration Time Curve From 0 to 4 Hours	-325.93 mg/dL*hour Interval -390.6 to -261.2

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

Blood samples were collected at specific intervals over a 4 hour period to measure blood glucose values following ingestion of a liquid meal and the process is repeated after 16 weeks of study drug administration following another liquid meal administration and blood glucose values measured at specific time points over 4 hours. The difference in the time to reach the maximal blood glucose value was then calculated between these two timepoints.

Outcome measures

Measure	iGlarLixi n=103 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration	-0.24 hour Interval -0.5 to 0.0

SECONDARY outcome

Timeframe: Week 16

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at Week 16 are reported.

Blood glucose level was determined based upon CGM data. Percentage of participants with glucose level <54 mg/dL for less than 15 minutes per day are reported.

Outcome measures

Measure	iGlarLixi n=100 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL	63.0 percentage of participants Interval 52.8 to 72.4

SECONDARY outcome

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

Population: Efficacy analysis set included all enrolled participants who received \>=1 dose of iGlarLixi and had evaluable CGM data at baseline. Only participants analyzed at baseline and Week 16 are reported.

The changes in diabetes medication treatment-related impact and satisfaction was measured by the DM-SAT. The DM-SAT is a 16-item measure with 4 domains/subscales assessing lifestyle (5 items), medical control (3 items), convenience (5 items) and well being (3 items). Each item is measured on a scale from 0-10, where 0= not at all satisfied, 1 to 3= not too satisfied, 4 to 6 = somewhat satisfied, 7-9= very satisfied and 10= extremely satisfied. The overall score was calculated as the sum of the 16 questions with a score that ranges from 0 to 160. A higher score indicates a positive result. Baseline is defined as the first 14 evaluable days of evaluable CGM data prior to first day of administration.

Outcome measures

Measure	iGlarLixi n=106 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire	0.18 units on a scale Interval 0.14 to 0.22

SECONDARY outcome

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)

Population: Safety set included all enrolled participants who received \>=1 dose of iGlarLixi.

Hypoglycemia event is defined as any event recorded in hypoglycemic event information library electronic case report form page that has "Yes" as the response to the question "Were any hypoglycemic events experienced".

American Diabetes Association (ADA) Level 1 hypoglycemia is defined as measurable glucose concentration <70 mg/dL [3.9 millimoles per liter (mmol/L)] but >=54 mg/dL (3.0 mmol/L).

ADA Level 2 hypoglycemia is defined as measurable glucose concentration <54 mg/dL (3.0 mmol/L) that needed immediate action.

ADA Level 3 hypoglycemia is defined as severe event characterized by altered mental and/or physical functioning that required assistance from another person for recovery of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest.

Participants might have experienced both Level 1 and 2 hypoglycemia events.

Outcome measures

Measure	iGlarLixi n=123 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels Any Hypoglycemia events	35 Participants
Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels Hypoglycemia events confirmed by ADA criteria	29 Participants
Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels ADA Level 1 hypoglycemia	26 Participants
Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels ADA Level 2 hypoglycemia	11 Participants
Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels ADA Level 3 hypoglycemia	0 Participants

SECONDARY outcome

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)

Population: Safety set included all enrolled participants who received \>=1 dose of iGlarLixi.

An AE is any untoward medical occurrence in a participant or clinical study participant, whether or not considered related to the study drug. An SAE is defined as any AE that, at any dose, meets one of the following criteria: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or congenital anomaly/birth defect. TEAEs is defined as AEs that developed, worsened, or became serious during the treatment-emergent period, defined as the time from the first administration of the study drug (Day 1) to the last administration of the study drug + 3 days.

Outcome measures

Measure	iGlarLixi n=123 Participants Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events Any TEAE	47 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events Any treatment-emergent SAE	1 Participants

Adverse Events

iGlarLixi

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	iGlarLixi n=123 participants at risk Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.81% 1/123 • Number of events 1 • TEAEs data was collected 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). Analysis was performed on the safety set.

Other adverse events

Measure	iGlarLixi n=123 participants at risk Participants received iGlarLixi subcutaneous injection once daily for 16 weeks.
Infections and infestations Upper Respiratory Tract Infection	5.7% 7/123 • Number of events 7 • TEAEs data was collected 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). Analysis was performed on the safety set.
Metabolism and nutrition disorders Hypoglycaemia	5.7% 7/123 • Number of events 19 • TEAEs data was collected 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). Analysis was performed on the safety set.

Additional Information

Trial Transparency Team

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Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
• Publication restrictions are in place

Restriction type: OTHER