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Type 2 Diabetes Treated With InsulinPhase 4IDEALNCT04945070

INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi

A Phase 4 study testing IGlarLixi and MDI - Multiple dose insulin injection in people with Type 2 Diabetes Treated With Insulin, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
IGlarLixi and MDI - Multiple dose insulin injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteCzechia
Study dates
Jul 2021to Jun 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
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  • 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),
  • 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),
  • 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

Trial locations and contacts

1 site in 1 country.

Martin Haluzik, MD, DSc contact

+420 261 36 ext. 4107

halm@ikem.cz

Czechia1 site, 1 recruiting

  • Institute for Clinical and Experimental Medicine

    Prague

    Milos Mraz, MD, PhD, mrzm@ikem.cz

    Recruiting

Other trials in Czechia

About this study

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.

Being tested
IGlarLixi, MDI - Multiple dose insulin injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IGlarLixiDrug

    Switching T2DM subjects from MDI to iGlarLixi

  • MDI - Multiple dose insulin injectionDrug

    Continuing with established MDI regimen

Study groups in NCT04945070
Study groupRoleWhat they receive
iGlarLixiExperimentalSubjects switched from MDI to iGlarLixi
Receives: Drug: IGlarLixi
ControlActive comparatorPatients continuing with previous MDI
Receives: Drug: MDI - Multiple dose insulin injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1C

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

    Measured: 6 months

Secondary outcomes (8)

  1. Hypoglycemia

    Number and time in hypoglycemia

    Measured: 6 months

  2. Compliance

    Adherence to treatment and recommended SMBG pattern

    Measured: 6 months

  3. Fasting plasma glucose

    Measured: 6 months

  4. Postprandial plasma glucose

    Measured: 6 months

  5. Glycemic variability

    Measured from continuous glucose monitoring

    Measured: 6 months

  6. Time in target range of 3.9-10 mmol/l

    Measured from continuous glucose monitoring

    Measured: 6 months

  7. Body weight

    Change in body weight

    Measured: 6 months

  8. Treatment Satisfaction

    Assessment of quality of life using Diabetes Treatment Satisfaction Questionnaire

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945070
Sponsor's protocol ID
IDEAL V2.2
Acronym
IDEAL
Status last verified
Jul 2021
First submitted
22 Jun 2021
Last updated
22 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38653903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IGlarLixi and MDI - Multiple dose insulin injection in people with Type 2 Diabetes Treated With Insulin, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin Haluzik, MD, DSc (+420 261 36 ext. 4107, halm@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1C (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945070, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.

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