INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

NCT04945070 | Unknown Phase 4

• 1 other identifier: IDEAL V2.2
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

• HbA1C

  The effect of the transition from MDI regimen to IGlarLixi on HbA1c values

  6 months

Secondary Outcomes (8)

• Hypoglycemia

  6 months

• Compliance

  6 months

• Fasting plasma glucose

  6 months

• Postprandial plasma glucose

  6 months

• Glycemic variability

  6 months

Other Outcomes (2)

• ALT

  6 months

• hsCRP

  6 months

Study Arms (2)

iGlarLixi

EXPERIMENTAL

Subjects switched from MDI to iGlarLixi

Drug: IGlarLixi

Control

ACTIVE COMPARATOR

Patients continuing with previous MDI

Drug: MDI - Multiple dose insulin injection

Interventions

IGlarLixi DRUG

Switching T2DM subjects from MDI to iGlarLixi

iGlarLixi

MDI - Multiple dose insulin injection DRUG

Continuing with established MDI regimen

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• At screening visit, age under legal age of adulthood (\<18 years),
• History of other diabetes than T2DM (type 1 diabetes T1DM, monogenic, secondary..)
• 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, MELD≥15) 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),

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Czechia

RECRUITING

Related Publications (1)

• Novodvorsky P, Thieme L, Lankova I, Mraz M, Taybani ZJ, Botyik B, Stella P, Vytasil M, Lauand F, Bonnemaire M, Haluzik M. The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial-Study Design and Protocol. Diabetes Ther. 2024 Jun;15(6):1461-1471. doi: 10.1007/s13300-024-01582-x. Epub 2024 Apr 24.

  PMID: 38653903 DERIVED

Central Study Contacts

Martin Haluzik, MD, DSc

CONTACT

+420 261 36; halm@ikem.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. MUDr. Martin Haluzik, DrSc.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

CZ (1)