A Phase 4 interventional study of Liraglutide and Placebo in Gestational Diabetes Mellitus, sponsored by Tina Vilsboll. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Tina Vilsboll · Phase 4, Interventional, and Prevention
It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy. Knowing this, we want to examine the effect of the type 2 diabetes medicine, liraglutide (Victoza), in women with previous gestational diabetes with the aim of reducing the risk of developing type 2 diabetes.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 105 is close to the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Tina Vilsboll is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for women with previous GDM:
Exclusion Criteria for women with previous GDM:
Inclusion criteria for women without previous GDM:
Exclusion Criteria for women without previous GDM :
Inclusion Criteria for women without previous GDM and without NAFLD:
Exclusion Criteria for women without previous GDM and without NAFLD:
Inclusion Criteria for women with biopsi-verified NAFLD:
Exclusion Criteria for women with biopsi-verified NAFLD:
1.8 mg liraglutide, subcutaneous, once-daily for five years
Drug: Liraglutide
Placebo, subcutaneous, once-daily for one year
Drug: Placebo
Control without previous GDM.
1.8 mg liraglutide
Also known as: Victoza, NN2211
Liraglutide without the GLP-1 analogue
Change in glucose tolerance
Changes in glucose is measured by area under the curve for the plasma glucose excursion following a 4-hour 75 g oral glucose tolerance test (OGTT)
Time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks
Deterioration in glycaemic status
Percentage of subjects in each treatment arm with normal glucose tolerance (NGT) at inclusion who develop impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) or type 2 diabetes; or with IFG or IGT who develop combined IFG/IGT; or with combined IFG/IGT who develop type 2 diabetes
Time frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks
Changes in glycated hemoglobin
Changes in glycated hemoglobin (HbA1c). From normoglycaemic to prediabetic or type 2 diabetic and from prediabetic to type 2 diabetic or normoglycaemic.
Time frame: From baseline to 52 wks and 260 wks
Changes in anthropometric measurements
Changes in body mass index (BMI)(kg/m2), absolute body weight (kg), and waist:hip ratio
Time frame: from baseline to 52 and 260 wks
Changes in beta cell secretory responses
changes in area under the curve during OGTT and isoglycemic intravenous glucose infusion (IIGI), the homeostatic model assessment (HOMA) and pro-insulin ratio
Time frame: from baseline to 52, 53, 260, and 261 wks
Changes in insulin sensitivity
assessed by HOMA-IR and Matsuda insulin sensitivity index
Time frame: from baseline to 52, 53, 260, and 261 wks
Changes in incretin hormone secretion
measured as fasting plasma concentrations and plasma responses of GLP-1, GLP2, and GIP and plasma glucagon during OGTT
Time frame: baseline to 52, 53, 260, and 261 wks
Changes in incretin effect
insulin and c-peptide responses after OGTT vs. IIGI
Time frame: baseline to 52, 53, 260, and 261 wks
Changes in presence of non-alcoholic fatty liver disease (NAFLD)
gamma-glutamyltranferase (GGT), intra-heptic fat, FGF-21, whole body and visceral fat mass/fat-free mass, circulating lipids, ultrasound scan and fibroscan
Time frame: baseline to 52 and 260 wks
Changes in cardio-metabolic risk measures
pro-collagen 3, GGT, Intra-hepatic fat, whole body and visceral fat mass/fat-free mass, circulating lipids and cardiovascular biomarkers (highly sensitive c-reactive protein (hs-CRP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP), tumor necrosis factor-alpha (TNF-alpha), adiponectin and plasminogen activator inhibior-1 (PAI-1))
Time frame: baseline to 52 and 260 wks
Changes in gut microbiota
optional to the main protocol
Time frame: baseline to 52 and 260 wks
Changes in subjective appetite
visual analogue scale (VAS)
Time frame: baseline to 52, 53, 260, and 261 wks
Number of participants with treatment-related adverse events (Safety and tolerability)
as assessed by validated questionnaires
Time frame: baseline to 52 and 260 wks
Change in Quality of life
Assessed by validated questionnaires (SF-36)
Time frame: Baseline to 52 and 260 wks
Evaluation of alcohol consumption
By validated questionnaires
Time frame: baseline to 52 and 260 wks
Evaluation of microalbuminuria
Predicitve value of biomarkers for detection of microalbuminuria
Time frame: baseline to 52 to 260 wks
Evaluation of blindedness of participants and investigators
questionnaire and the end of the blinded trial
Time frame: baseline to 52 wks
Changes in bonemarkers
Time frame: baseline to 52 and 260 wks
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tina Vilsboll