NCT03087032 Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD)
| NCT ID | NCT03087032 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Type 2 Diabetes Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2019-01-10 |
| Primary Completion | 2025-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 164 participants in total. It began in 2019-01-10 with a primary completion date of 2025-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Xuejun Li, MD
PRINCIPAL INVESTIGATOR
The first afilliated hospital of Xiamen university
Frequently Asked Questions
Who can join the NCT03087032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Type 2 Diabetes Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03087032 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03087032 currently recruiting?
Yes, NCT03087032 is actively recruiting participants. Contact the research team at liuchangqin@xmu.edu.cn for enrollment information.
Where is the NCT03087032 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT03087032 clinical trial?
NCT03087032 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Xuejun Li, MD at The first afilliated hospital of Xiamen university. The trial plans to enroll 164 participants.
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