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UnknownPhase 3

Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy

Efficacy and Safety Of Different Hypoglycemic Regimens Compared With Premixed Insulin In Patients With Type 2 Diabetes Receiving Short-term Intensive Insulin Therapy

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

78

estimated

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≥9%

Primary endpoints

HbA1c, changeHbA1c <7.0% achievementAmplitude of glycemic excursions

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 IDNCT05545800
Org study ID202206361

Timeline

Milestones

Study start2022-09-01actual
Study first posted2022-09-19actual
Last update posted2022-09-19actual
Primary completion2024-06-01estimated
Study completion2024-06-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria)
BMI 21~32Kg/m2
duration of T2DM more than 1 year
FPG≥11.1mmol/L or HbA1c ≥9% for three months
fasting C-peptide >1 ng/mL

Exclusion criteria

acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month;
impaired renal function,defined as (but not limited to) serum creatinine levels ≥1.5 mg/dL for males and ≥1.4 mg/dL for females, or the presence of macroproteinuria (> 2 g/day)
pregnancy
inability to perform self-monitoring of BG (SMBG)
acute disease or surgery in the past 3months or preparation for the surgey

Endpoints (5)

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

Glycemic / diabetes
3
Safety / tolerability / PK
2

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Mean Change From Baseline in HbA1c

Time frame:Month 0 to 3

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Percentage of patients achieving HbA1c <7%

Time frame:Month 0 to 3

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Primary/protocol endpoint

Amplitude of glycemic excursions

Time frame:Month 0 to 3

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Percentage of hypoglycemia incidence

Time frame:Month 0 to 3

threshold achievement, event

Secondary/protocol endpoint

Percentage of adverse events

Time frame:Month 0 to 3

Treatment-emergent AEs (any)

descriptive

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.