De-intensification of intensive insulin therapy using the combination of long-acting insulin glargin and GLP-1 receptor agonist lixisenatide

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi - IDEAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003715-94-CZ

Enrollment

100

Registered

2020-10-02

Start date

2020-12-17

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Trade Name: Suliqua Pharmaceutical Form: Solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetes mellitus • Intensive insulin therapy with at least 3 doses of prandial insulin and one dose of basal insulin/day for at least 3 months prior to screening • Total daily insulin dose = 0.8 IU/kg • Fasting C peptide above the lower limit of the normal range • Treatment with metformin (unless intolerance to metformin use is present) • HbA1c = 75 mmol/mol (9%) • HbA1c 76-86 mmol/mol (9.1-10%) in case of proven non-compliance with MDI regimen • Age 18-80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Other diabetes types – type 1, secondary • Any contraindication to the use of GLP-1 receptor agonists • Daily dose of basal insulin >50 units/day • Acute myocardial infarction, unstable angina pectoris, stroke, pulmonary embolism 3 months prior to inclusion • Chronic heart failure NYHA III-IV • Chronic kidney disease CKD IIIb-IV, end-stage renal disease • Acute or chronic liver failure • Clinically significant gastroparesis • Active malignancy • Haemoglobin < 100 g/l • Pregnancy, breast-feeding, or in case of women with child-bearing potential willingness to be pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of the transition from multiple dose insulin regimen to the combination of insulin glargine and lixisenatide on metabolic control (HbA1c) in participants with T2DM during a 6-month intervention period.;Secondary Objective: •to assess the safety of both treatment regimes in relation to incidence and event-rates of hypoglycemia using multiple hypoglycaemia definitions (cut-off, timing) •to assess patients’ compliance (adherence to treatment and the recommended SMBG pattern) •to assess other parameters of metabolic compensation including fasting plasma glucose and mean postprandial plasma glucose (calculated from 3 postprandial values taken after 3 main meals of the day), glycaemic variability of self-monitored fasting blood glucose, time in designated target range measured with CGM etc. •to assess the effect of both treatment regimens on body weight •to assess the effect of MDI to IGlarLixi transition on quality of life, treatment burden and fear of hypoglycemia •to assess the effect of both treatment regimens on selected exploratory laboratory parapeters including levels of adipokines, markers of hepatic steatosis and markers of low-grade inflammation ;Primary end point(s): Mean change in HbA1c;Timepoint(s) of evaluation of this end point: 6 months after initiation of treatment with IMP	—

Measure

Time frame

Main Objective: To investigate the effect of the transition from multiple dose insulin regimen to the combination of insulin glargine and lixisenatide on metabolic control (HbA1c) in participants with T2DM during a 6-month intervention period.;Secondary Objective: •to assess the safety of both treatment regimes in relation to incidence and event-rates of hypoglycemia using multiple hypoglycaemia definitions (cut-off, timing) •to assess patients’ compliance (adherence to treatment and the recommended SMBG pattern) •to assess other parameters of metabolic compensation including fasting plasma glucose and mean postprandial plasma glucose (calculated from 3 postprandial values taken after 3 main meals of the day), glycaemic variability of self-monitored fasting blood glucose, time in designated target range measured with CGM etc. •to assess the effect of both treatment regimens on body weight •to assess the effect of MDI to IGlarLixi transition on quality of life, treatment burden and fear of hypoglycemia •to assess the effect of both treatment regimens on selected exploratory laboratory parapeters including levels of adipokines, markers of hepatic steatosis and markers of low-grade inflammation ;Primary end point(s): Mean change in HbA1c;Timepoint(s) of evaluation of this end point: 6 months after initiation of treatment with IMP

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Secondary

Measure	Time frame
Secondary end point(s): - proportion of patients with at least one episode of hypoglycemic event (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs) - proportion of patients with severe (third-party assistance) hypoglycemic event - hypoglycemia event-rate (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs) - change in percentage of time in hypoglycemia (3.9 mmol/l and 3.0 mmol/l cut-offs) range (by CGM) from BL to M6 - number of missed injection doses detected by smart cap (vs the number of recommended injections relating to BB/Suliqua) - change in FPG from BL to M6 - change in mean postprandial glucose (calculated as the mean of ppgs after 3 main meals of the daily BG profile measured at BL and M6) - change in glycemic variability measured as change in SD of fasting SMPG from BL to M6 - Change in glycemic variability evaluated by CGM from BL to M6 - change in percentage of time being spent within 4.0 – 10.0 mmol/l (70-180 mg/dl) range detected by CGM at BL vs at M6 - change in body weight from BL to M6 - change in QoL/treatment satisfaction from BL to M6 - Adverse Events;Timepoint(s) of evaluation of this end point: 6 months after initiation of treatment with IMP	—

Measure

Time frame

Secondary end point(s): - proportion of patients with at least one episode of hypoglycemic event (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs) - proportion of patients with severe (third-party assistance) hypoglycemic event - hypoglycemia event-rate (24-hour, nocturnal (from bedtime to waking up), with 3.9 mmol/l and 3.0 mmol/l cut-offs) - change in percentage of time in hypoglycemia (3.9 mmol/l and 3.0 mmol/l cut-offs) range (by CGM) from BL to M6 - number of missed injection doses detected by smart cap (vs the number of recommended injections relating to BB/Suliqua) - change in FPG from BL to M6 - change in mean postprandial glucose (calculated as the mean of ppgs after 3 main meals of the daily BG profile measured at BL and M6) - change in glycemic variability measured as change in SD of fasting SMPG from BL to M6 - Change in glycemic variability evaluated by CGM from BL to M6 - change in percentage of time being spent within 4.0 – 10.0 mmol/l (70-180 mg/dl) range detected by CGM at BL vs at M6 - change in body weight from BL to M6 - change in QoL/treatment satisfaction from BL to M6 - Adverse Events;Timepoint(s) of evaluation of this end point: 6 months after initiation of treatment with IMP

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Countries

Czech Republic, Hungary

Contacts

Public ContactClinical Trial Infomation

Institute for Clinical and Experimental Medicine

mrzm@ikem.cz

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026