INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    96
  • sponsor
    Institute for Clinical and Experimental Medicine
Updated on 31 July 2021

Summary

Intensive insulin therapy using multiple daily injections (MDI) constitutes the most intense type of regimen in type 2 diabetes mellitus (T2D). Although highly effective in lowering blood glucose, it can also increase the risk of hypoglycemia, promote weight gain and cause significant treatment burden for the patients. As demonstrated by a number of clinical studies, overtreatment is a common and generally unrecognized problem in patients with T2D; nevertheless, medication de-escalation is still infrequent in everyday clinical practice. IGlarLixi is a once-daily fixed-ratio combination (FRC) of a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA), which can offer similar efficacy in glucose control with lower rates of hypoglycemia and smaller weight gain that basal insulin regimens. The aim of our randomised, controlled study is to examine prospectively the safety and efficacy of de-escalating MDI regimens to iGlarLixi in T2D adult patients.

Details
Condition Type 2 Diabetes Treated With Insulin
Treatment iGlarLixi, MDI - Multiple dose insulin injection
Clinical Study IdentifierNCT04945070
SponsorInstitute for Clinical and Experimental Medicine
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed written informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Adult participants with T2DM
Participants who have been treated with a an MDI regimen comprising of at least 3 doses of prandial insulin per day and one dose of basal insulin per day for at least 3 months before the screening visit
Participants treated with metformin (unless intolerance to metformin use is present) SGLT2i at stable doses for at least 3 months prior screening
Total daily insulin dose 0.8 IU/kg
Fasting C peptide above the lower limit of the normal range
HbA1c at screening visit 75 mmol/mol (9%) as measured by local laboratory
HbA1c at screening visit 76-86 mmol/mol (9.1-10%) as measured by local laboratory in case of proven non-compliance with MDI regimen

Exclusion Criteria

At screening visit, age under legal age of adulthood (<18 years)
History of other diabetes than T2DM (type 1 diabetes T1DM, monogenic, secondary..)
Use of any oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within the last 3 months before screening
History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy
Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to screening visit
Comorbidity (such as but not limited to rheumatoid arthritis) with continuous, intermittent or expected systemic glucocorticoid therapy during the next 30 weeks after screening visit
Use of weight loss drugs within 3 months prior to screening visit
Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit
Within the last 3 months prior to screening visit: history of stroke, pulmonary embolism, myocardial infarction, unstable angina, or heart failure requiring hospitalization
Chronic hear failure NYHA stages III-IV
Acute or chronic liver failure - established diagnosis of acute or chronic liver failure (Child-Pugh 3, MELD15) or liver cirrhosis
Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
Known history of drug or alcohol abuse within 6 months prior to the time of screening visit
Active malignancy
Anaemia with haemoglobin < 100 g/l at baseline
Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the last 3 months prior to the screening visit)
Participants with conditions/concomitant diseases precluding their safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.)
Impossibility to meet specific protocol requirements (eg, scheduled visits, participants unable to fully understand participant's study documents and to complete them, etc.)
Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (eg, participant unable or unwilling to do self-injections or blood glucose monitoring using the sponsor-provided blood glucose meter at home, etc.)
Participant is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Participation in another clinical trial
Pregnancy or lactation
Women of childbearing potential not protected by highly effective contraceptive method of birth control (definition see section [10.1.1.1](telnet://10.1.1.1))
Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit or history of surgery affecting gastric emptying
History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy had now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy
Personal or immediate family history of MTC or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes)
Participant who has a renal function impairment with creatinine clearance <30 mL/min (using the eGFR) or end-stage renal disease (ie. CKD stage IV or V)
History of allergic reaction to any GLP-1 RA in the past
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