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

Short name LiraGooD

NCTNCT03087032Other idKYH2017-002

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 164 participants (estimated)
Sponsor: The First Affiliated Hospital of Xiamen University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 10 Jan 2019
Primary completion: 15 Jan 2025 (estimated)
Completion: 10 Feb 2025 (estimated)
First posted: 22 Mar 2017
Last update posted: 13 Jan 2025
Conditions: Type 2 Diabetes Patients · Overweight and Obesity · Hyperglycaemia (Diabetic)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202220242026

Ph 4
LiraGooD
NCT03087032
10 Jan 2019 to est. 10 Feb 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial is carried to investigate and evaluate the efficacy and safety of Liraglutide in combination with prandial insulin therapy vs insulin glargine in combination with prandial insulin therapy in overweight / obese patients with uncontrolled type 2 diabetes.

Interventions

LiraglutideDrug
insulin glargineDrug

Arms2

Experimental
Liraglutide-bolus
'Liraglutide-bolus'(Liraglutide once-daily plus thrice-daily prandial insulin lispro). Patients will receive adding Liraglutide to prandial insulin Lispro. The starting liraglutide dose was 0.6mg/day, then 1.2mg/day after 1 week and 1.8mg/day after a further week. The dose was maintained until study completion. Dose of insulin Lispro will be instructed on a titration schedule, adjusted every 3 days.
Active comparator
Basal-bolus
'Basal-bolus' (insulin glargine once-daily plus thrice-daily prandial insulin lispro). Patients will receive adding insulin Glargine to prandial insulin Lispro.Dose of insulin will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
the net difference in the proportion of patients with HbA1c \< 7.0% without experiencing hypoglycemia and without weight gain is more than 3%

Secondary outcomes(11)

the proportion of patients with hypoglycemia
Time frame · 24 weeks
Registry description
the proportion of patients with hypoglycemia
changes in HbA1c
Time frame · 24 weeks
Registry description
changes in HbA1c
changes from baseline in FPG(mmol/L)
Time frame · 24 weeks
Registry description
changes from baseline in FPG(mmol/L)
changes in body weight ( kilograms)
Time frame · 24 weeks
Registry description
changes in body weight( kilograms)
changes in prandial insulin dosage （per kilogram）
Time frame · 24 weeks
Registry description
changes in prandial insulin dosage （per kilogram）
changes in visceral as assessed by dual x-ray absorptiometry (DXA)
Time frame · 24 weeks
Registry description
changes in visceral as assessed by dual x-ray absorptiometry (DXA)
number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Time frame · 24 weeks
Registry description
number of participants with abnormal laboratory values and/or adverse events
changes in serum c-peptide level
Time frame · 24 weeks
Registry description
changes in serum c-peptide level
changes in systolic pressure
Time frame · 24 weeks
Registry description
changes in systolic pressure
changes in diastolic pressure
Time frame · 24 weeks
Registry description
changes in diastolic pressure
changes in serum lipid profile
Time frame · 24 weeks
Registry description
changes in serum lipid profile

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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