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

NCT03087032 | Recruiting Phase 4 DMC

• 1 other identifier: KYH2017-002
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Patients; Overweight and Obesity; Hyperglycaemia (Diabetic)

Keywords

Liraglutide; Insulin Glargine; Prandial Insulin

Outcome Measures

Primary Outcomes (1)

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

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

  24 weeks

Secondary Outcomes (11)

• the proportion of patients with hypoglycemia

  24 weeks

• changes in HbA1c

  24 weeks

• changes from baseline in FPG(mmol/L)

  24 weeks

• changes in body weight ( kilograms)

  24 weeks

• changes in prandial insulin dosage （per kilogram）

  24 weeks

Study Arms (2)

Liraglutide-bolus

EXPERIMENTAL

'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.

Drug: Liraglutide

Basal-bolus

ACTIVE COMPARATOR

'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.

Drug: insulin glargine

Interventions

Liraglutide DRUG

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.

Also known as: Victozaa, Liraglutid, Liroglutide, Liraglutidum, Liraglutide Acetate

Liraglutide-bolus

insulin glargine DRUG

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.

Also known as: Lantus

Basal-bolus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The first afilliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Hyperglycemia

Interventions

Liraglutide; Insulin Glargine

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Xuejun Li, MD

  The first afilliated hospital of Xiamen university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changqin Liu, MD

CONTACT

+86-133-7698-6106; liuchangqin@xmu.edu.cn

Xin Zheng, MD

CONTACT

+86-187-0592-9102; 88126386@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 22, 2017
• Study Start: January 10, 2019
• Primary Completion: January 15, 2025
• Study Completion: February 10, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)