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

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Mar 16, 2017

Keywords

ClinConnect Summary

The LiraGooD clinical trial is studying two different ways to manage blood sugar levels in overweight or obese adults with type 2 diabetes who are not fully controlled by their current treatment. Specifically, it compares the effects of Liraglutide, a medication that helps regulate blood sugar, combined with prandial insulin (insulin taken at mealtimes) against insulin glargine, another type of insulin, also used with prandial insulin. This study will last for 24 weeks and aims to find out which treatment is more effective and safer for patients.

To participate in the trial, you must be between 18 and 75 years old, have a body mass index (BMI) between 24 and 45, and have type 2 diabetes that meets specific criteria, such as having a high blood sugar level (HbA1c ≥ 7.5%). However, there are certain health conditions that would exclude you, like a history of pancreatic issues or significant heart disease. If eligible, participants will be involved in a study where they will receive either of the two treatments and will be monitored for their blood sugar levels and overall health. This trial is currently recruiting participants, and those who join will help researchers understand better ways to manage diabetes in overweight and obese patients.

Gender

ALL

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