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 (Soli-CGM)

  • STATUS
    Recruiting
  • End date
    Mar 6, 2023
  • participants needed
    100
  • sponsor
    Sanofi
Updated on 28 October 2022
insulin
type 2 diabetes mellitus
hemoglobin a1c
antidiabetic agents
continuous glucose monitoring

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

Details
Condition Type 2 Diabetes Mellitus
Treatment Insulin glargine/Lixisenatide
Clinical Study IdentifierNCT05114590
SponsorSanofi
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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