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 range18 Years

SexALL

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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…

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