Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes (Liragest)

Obese women with history of gestational diabetes are in great danger to develop type 2 diabetes (T2D) within 5-10 years after delivery. Aim of the study is to investigate if 12 months' liraglutide treatment could decrease the risk of T2D in obese women who have had gestational diabetes. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group, once daily. Same laboratory tests are taken and instructions given at baseline 6 month and one year. After one year visits once a year until 5 years with same laboratory tests and measurements are taken.

Study Overview

• Status: Active, not recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Drug: Liraglutide 6 MG/ML [Victoza]; Drug: Placebos

Detailed Description

Incidence of type 2 diabetes (T2D) is increasing along with pandemia of obesity. Gestational diabetes is the major risk factor for T2D in women and more than every tenth will develop gestational diabetes during pregnancy. T2D can be prevented by weight loss. Health care professionals should take advantage of this opportunity to prevent this devastating disease in women.

Aim of the study is to investigate if 12 months' liraglutide treatment (1.8 mg) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin.

100 women, who have had gestational diabetes with treatment with metformin and/or insulin and who have stopped lactation and are not pregnant are enrolled between 6 to 18 months after delivery. BMI should be ≥30 kg/m2. The women are randomized either to liraglutide (Victoza ® 1.8 mg) or placebo group. Both treatments are given by similar device s.c. once daily during 365 days. Before starting the treatment, clinical examination and laboratory test are done. Similar dietary instructions are given. Same laboratory tests are taken and instructions given at 6 months and at one year after baseline. Additional follow-up call (AE reporting) is scheduled at 3 months and a drug dispensing visit at 9 months. After one year visits once a year until 5 years with same laboratory tests and measurements are taken. Primary end-point is development of T2D (fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in oral glucose tolerance test 75g, and/or HbA1c≥ 6.5 %) from year 1 to 5.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• history of gestational diabetes with treatment with metformin and/or insulin
• delivery 6 to 18 months before screening
• BMI ≥30 kg/m2
• use of contraceptives (IU-device or oral contraceptive)

Exclusion Criteria:

• lactation
• pregnancy
• type 1 or type 2 diabetes
• use of antidepressives, statins or anti-hyperglycemic therapies
• severe hepatic insufficiency
• end stage renal disease
• history of pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebos; Starting dose of placebo 0.1 ml will be administered for one week, after which dose will be escalated to placebo 0.2 ml for one week and thereafter placebo 0.3 ml s.c. daily injections.
Active Comparator: liraglutide	Drug: Liraglutide 6 MG/ML [Victoza]; Starting dose of liraglutide 0.6 mg will be administered for one week, after which dose will be escalated to liraglutide 1.2 mg for one week and thereafter liraglutide 1.8 mg s.c. daily injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of type 2 diabetes	assessed by fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in oral glucose tolerance test (OGTT) 75g, and/or HbA1c≥ 6.5 %	from year 1 to 5

Collaborators and Investigators

• Sponsor: Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: T160/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No