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Completed

Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

1

Recruiting sites

Enrollment

150

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≤7.5%

Primary endpoints

HbA1c <6.5% achievement (HbA1c <7.0% achievement, HbA1c <6.5% achievement)Body weight, absolute change (kg)Risk of hypoglycemia from baseline to 3, 6, 9 and 12 months

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04020445
Org study IDBekesCCH

Timeline

Milestones

Study start2016-01-01actual
Study first posted2019-07-16actual
Primary completion2022-01-01actual
Study completion2022-01-01actual
Last update posted2023-02-13actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Sampling methodNon probability sample

Study population text

Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.

Inclusion criteria

Type 2 diabetic (T2D) patients >18 years old
detectable random, non-fasting serum C-peptide levels
HbA1c=< 7.5%
treated with MDI (with stable daily doses of insulin at least for 90 days prior to baseline visit)
using relatively low total daily insulin dose (TDD), at baseline visit low TDD is defined as TDD<70 IU/day and TDD<0.6 IU/kg/day at the same time.

Exclusion criteria

Type 1 diabetes
treatment of T2D with any medication for diabetes other than insulin or metformin during 90 days before baseline visit
active cancer
anaemia (haemoglobin <100g/l)
acute or chronic kidney disease with an estimated glomerular filtration rate <30 mL/min/1.73 m2

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

change in body weight from baseline to 3, 6, 9 and 12 months

Time frame:it is checked at baseline and at 3, 6, 9 and 12 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Number of participants reaching HbA1c<7% and HbA1c<6.5%

Time frame:it is checked at baseline and at 3, 6, 9 and 12 months

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months

Time frame:it is checked at baseline and at 3, 6, 9 and 12 months

change from baseline, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.