CompletedPhase 4

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

United States124 participantsStarted 2022-01-27

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 clin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05114590

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-28

Results submitted2024-03-20

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials