Phase 4
N=124
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
Bottom Line
View on ClinicalTrials.gov: NCT05114590 ↗Enrolled (actual)
124
Serious AEs
0.8%
Results posted
May 2024
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin glargine/Lixisenatide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)] |
26.22 | — |
| SECONDARY Percent Change From Baseline to Week 16 in Glucose Total Coefficient of Variation (CV) |
5.0 | — |
| SECONDARY Change From Baseline to Week 16 in Mean Daily Blood Glucose |
-52.48 | — |
| SECONDARY Change From Baseline to Week 16 in the Maximum Postprandial Glucose Exposure in the 4 Hours Post-Breakfast Meal |
-73.66 | — |
| SECONDARY Change From Baseline to Week 16 in Time Above Range (>180 mg/dL) |
-28.67 | — |
| SECONDARY Percentage of Participants Who Achieved Coefficient of Variation <36% |
76.0 | — |
| SECONDARY Change From Baseline to Week 16 in Time in Range Per Time Blocks |
27.89; 33.73; 31.05; 25.87; 30.21 | — |
| SECONDARY Percentage of Participants Who Achieved Glucose Management Indicator (GMI) <7% and <9% |
43.0; 85.0 | — |
| SECONDARY 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 | — |
| SECONDARY Change From Baseline to Week 16 in Time to Reach Maximum Postprandial Glucose Concentration |
-0.24 | — |
| SECONDARY Percentage of Participants Who Spent <15 Minutes/Day at a Glucose Level <54 mg/dL |
63.0 | — |
| SECONDARY 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 | — |
| SECONDARY Number of Participants With Confirmed Hypoglycemia Measured by Blood Glucose Levels |
35; 29; 26; 11; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events |
47; 1 | — |
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
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05114590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.