Current partner codePEPTIDESDE
NCT03087032·Phase 4·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 4

Enrollment

164

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

An increasing number of patients with type 2 diabetes are treated with insulin. Patients with diabetes receiving intensive insulin therapy with various combinations of basal and prandial insulin can be caught in a vicious but common cycle, whereby insulin requirements increase over time, and this in turn contributes to weight gain and hypoglycemia and further increases in insulin dosing. At this stage, clinicians observe a practical limit to the efficacy of insulin titration alone on glucose-lowering and often add or continue metformin to reduce insulin resistance. Injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs), such as liraglutide, are a relatively new addition to our treatment armamentarium. These drugs improve glucose control and insulin sensitivity and contribute to weight loss. Treatment with basal insulin plus GLP-1RAs is well-established in diabetes guidelines and may be as effective as adding prandial insulin therapy. When GLP-1 RAs are started, a preemptive reduction in insulin dosage by 25% to 30% in patients with HbA1c \< 9% may reduce the risk for hypoglycemia. In overweight/obese patients with uncontrolled type 2 diabetes treated with more than three oral antidiabetic drugs (OADs) or high doses of premix insulin, Is basal-prandial insulin therapy the option treatment algorithm? Such an intensification strategy carries risk of increased hypoglycaemia and weight gain, both of which are associated with worse long-term outcomes. There have no randomized, controlled trials to evaluate the efficacy and safety of GLP-1 RAs vs insulin glargine added to prandial insulin in overweight/obese patients with uncontrolled type 2 diabetes. So, the current 24-week, prospective, open-label, randomized, multicenter, parallel group trial will be preformed to assess whether Liraglutide plus prandial insulin therapy was superior to glargine plus prandial insulin therapy in overweight/obese patients with uncontrolled type 2 diabetes.

Interventions

Treatment arms and agents.

DRUG

Liraglutide

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.

DRUG

insulin glargine

Individuals randomized to adding insulin Glargine to prandial insulin Lispro will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.

Timeline

From registration to results.

  1. First posted

    Mar 22, 2017

  2. Study start

    Jan 10, 2019

  3. Primary completion

    Jan 15, 2025

  4. Study completion

    Feb 10, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 13, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

the proportion of patients with hypoglycemia

Time frame · 24 weeks

the proportion of patients with hypoglycemia

changes in HbA1c

Time frame · 24 weeks

changes in HbA1c

changes from baseline in FPG(mmol/L)

Time frame · 24 weeks

changes from baseline in FPG(mmol/L)

changes in body weight ( kilograms)

Time frame · 24 weeks

changes in body weight( kilograms)

changes in prandial insulin dosage (per kilogram)

Time frame · 24 weeks

changes in prandial insulin dosage (per kilogram)

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

Time frame · 24 weeks

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

number of participants with abnormal laboratory values and/or adverse events

changes in serum c-peptide level

Time frame · 24 weeks

changes in serum c-peptide level

changes in systolic pressure

Time frame · 24 weeks

changes in systolic pressure

changes in diastolic pressure

Time frame · 24 weeks

changes in diastolic pressure

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

The first afilliated hospital of Xiamen university

Xiamen, Fujian, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.