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LiraGooD

RecruitingPhase 4

Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)

Efficacy and Safety of Liraglutide-bolus (Liraglutide Plus Prandial Insulin) Versus Glargine-bolus Therapy in Overweight / Obese Patients With Uncontrolled Type 2 Diabetes (LiraGooD)--A Multicenter Randomized Controlled Study

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

164

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

BMI ≥24HbA1c ≥9%

Primary endpoint

HbA1c <7.0% achievement (HbA1c <7.0% achievement, Documented hypoglycemia, Body weight, absolute change (kg))

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 IDNCT03087032
Org study IDKYH2017-002

Timeline

Milestones

Study first posted2017-03-22actual
Study start2019-01-10actual
Last update posted2025-01-13actual
Primary completion2025-01-15estimated
Study completion2025-02-10estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Age: 18 - 75 years old.
BMI must be greater than 24 and less than 45 kg/m2
Patients with type 2 diabetes who met the World Health Organization (who) diagnostic criteria (1999).
Newly diagnosed type 2 diabetic patients with HbA1c ≥ 9.0%;or patients with uncontrolled type 2 diabetes (HbA1c ≥ 7.5% ) who have received at least two types of oral hypoglycemic drugs (the dose of each drug needs to reach the second largest dose or more), or only insulin (excluding basal-bolus insulin therapy), or insulin with oral hypoglycemic drugs.
Signed informed consent.

Exclusion criteria

History of pancreatic disease,
History of medullary thyroid carcinoma
Lipase level > 3 times above normal,
Creatinine clearance ≤ 30 mL/min/1.73m2,
Evidence in the last 6 months of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty, congestive heart failure (New York Heart Association Functional Classification III-IV), or severe ischemic heart disease.
Preparation for pregnancy or having been in pregnancy
Researchers believe that there are any factors that affect assessing subjects' participation in trial.
Patients unable to cooperate in clinical trials

Endpoints (12)

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
5
Cardiometabolic biomarkers
3
Weight & body composition
2
Safety / tolerability / PK
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

changes in body weight ( kilograms)

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

changes in visceral as assessed by dual x-ray absorptiometry (DXA)

Time frame:24 weeks

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%

Time frame:24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

changes in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

changes from baseline in FPG(mmol/L)

Time frame:24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

changes in prandial insulin dosage (per kilogram)

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

changes in serum c-peptide level

Time frame:24 weeks

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

changes in systolic pressure

Time frame:24 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

changes in diastolic pressure

Time frame:24 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

changes in serum lipid profile

Time frame:24 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

the proportion of patients with hypoglycemia

Time frame:24 weeks

threshold achievement, event

Secondary/protocol endpoint

number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any)

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.