Liraglutide in the Prevention of Type 2 Diabetes After Gestational Diabetes

NCT04324229 | Active Not Recruiting

• 1 other identifier: T160/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

liraglutide

ACTIVE COMPARATOR

Drug: Liraglutide 6 MG/ML [Victoza]

placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Liraglutide 6 MG/ML [Victoza] DRUG

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.

liraglutide

Placebos DRUG

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.

placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant in Endocrinology

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 27, 2020
• Study Start: February 7, 2020
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

FI (1)