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The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novo Nordisk A/S
Rigshospitalet, Denmark
Hvidovre University Hospital
Herlev Hospital
Hillerod Hospital, Denmark
University of Copenhagen
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01795248
First received: February 18, 2013
Last updated: September 14, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention Phase
Gestational Diabetes Mellitus Drug: Liraglutide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Tina Vilsboll, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Change in glucose tolerance [ Time Frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks ]
    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)


Secondary Outcome Measures:
  • Deterioration in glycaemic status [ Time Frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks ]
    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


Other Outcome Measures:
  • Changes in glycated hemoglobin [ Time Frame: From baseline to 52 wks and 260 wks ]
    Changes in glycated hemoglobin (HbA1c). From normoglycaemic to prediabetic or type 2 diabetic and from prediabetic to type 2 diabetic or normoglycaemic.

  • Changes in anthropometric measurements [ Time Frame: from baseline to 52 and 260 wks ]
    Changes in body mass index (BMI)(kg/m2), absolute body weight (kg), and waist:hip ratio

  • Changes in beta cell secretory responses [ Time Frame: from baseline to 52, 53, 260, and 261 wks ]
    changes in area under the curve during OGTT and isoglycemic intravenous glucose infusion (IIGI), the homeostatic model assessment (HOMA) and pro-insulin ratio

  • Changes in insulin sensitivity [ Time Frame: from baseline to 52, 53, 260, and 261 wks ]
    assessed by HOMA-IR and Matsuda insulin sensitivity index

  • Changes in incretin hormone secretion [ Time Frame: baseline to 52, 53, 260, and 261 wks ]
    measured as fasting plasma concentrations and plasma responses of GLP-1, GLP2, and GIP and plasma glucagon during OGTT

  • Changes in incretin effect [ Time Frame: baseline to 52, 53, 260, and 261 wks ]
    insulin and c-peptide responses after OGTT vs. IIGI

  • Changes in cardio-metabolic risk measures [ Time Frame: baseline to 52 and 260 wks ]
    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))

  • Changes in gut microbiota [ Time Frame: baseline to 52 and 260 wks ]
    optional to the main protocol

  • Changes in subjective appetite [ Time Frame: baseline to 52, 53, 260, and 261 wks ]
    visual analogue scale (VAS)

  • Number of participants with treatment-related adverse events (Safety and tolerability) [ Time Frame: baseline to 52 and 260 wks ]
    as assessed by validated questionnaires

  • Change in Quality of life [ Time Frame: Baseline to 52 and 260 wks ]
    Assessed by validated questionnaires (SF-36)

  • Evaluation of alcohol consumption [ Time Frame: baseline to 52 and 260 wks ]
    By validated questionnaires

  • Evaluation of microalbuminuria [ Time Frame: baseline to 52 to 260 wks ]
    Predicitve value of biomarkers for detection of microalbuminuria

  • Evaluation of blindedness of participants and investigators [ Time Frame: baseline to 52 wks ]
    questionnaire and the end of the blinded trial

  • Changes in bonemarkers [ Time Frame: baseline to 52 and 260 wks ]

Enrollment: 105
Study Start Date: July 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide
1.8 mg liraglutide, subcutaneous, once-daily for five years
Drug: Liraglutide
1.8 mg liraglutide
Other Names:
  • Victoza
  • NN2211
Placebo Comparator: Placebo
Placebo, subcutaneous, once-daily for one year
Drug: Placebo
Liraglutide without the GLP-1 analogue
No Intervention: Control
Control without previous GDM.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for women with previous GDM:

  • Informed oral and written consent
  • Previous diagnosis of GDM according to current Danish guidelines (mainly PG concentrationa t 120 min after 75 g OGTT ≥ 9.0 mM) during pregnancy within the last 5 years
  • Age >18 years
  • 25 kg/m2 < BMI < 45 kg/m2
  • NGT, IFG and or IGT
  • Safe contraception and negative pregnancy test

Exclusion Criteria for women with previous GDM:

  • Patients with diabetes
  • HbA1c ≥6.5%
  • Patients with previous pancreatitis or previous neoplasia
  • Pregnant or breast feeding women
  • Anaemia (haemoglobin <7 mM)
  • Women planning to become pregnant within the next 5 years
  • Women using other contraception than intrauterine device (IUD) or oral contraceptives. Women who do not use safe contraception will be offered application of an IUD.
  • Women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens)
  • Ongoing abuse of alcohol or narcotics
  • Impaired hepatic function (liver transaminases >3 times upper normal limit)
  • Impaired renal function (se-creatinine >120 μM and/or albuminuria)
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg)
  • Any condition that the investigator feels would interfere with trial participation
  • Receiving any investigational drug within the last 3 months

Inclusion criteria for women without previous GDM:

  • Informed oral and written consent
  • Age >18 years
  • 25 kg/m2 < BMI < 45 kg/m2
  • NGT
  • Safe contraception and negative pregnancy test
  • Pregnancy within the last ten years without GDM

Exclusion Criteria for women without previous GDM :

  • Pregnant or breast feeding women
  • Anaemia (haemoglobin <7 mM)

Inclusion Criteria for women without previous GDM and without NAFLD:

  • Informed oral and written consent
  • Age >18 years
  • 25 kg/m2 < BMI < 45 kg/m2
  • NGT
  • At least one pregnancy witin the last ten years without GDM

Exclusion Criteria for women without previous GDM and without NAFLD:

  • Pregnant or breast feeding women
  • Anaemia (haemoglobin <7 mM)
  • Steatosis as assessed by ultrasound scanning
  • Recieving any investigational drug within the last 3 months
  • Any condition that the investigator feels would interfere with the trial participation

Inclusion Criteria for women with biopsi-verified NAFLD:

  • Informed oral and written consent
  • Women with known NAFLD or NASH
  • Age >18 years
  • 25 kg/m2 < BMI < 45 kg/m2
  • NGT
  • At least one prior pregnancy

Exclusion Criteria for women with biopsi-verified NAFLD:

  • women with established cirrhosis
  • Pregnant or breast feedning women
  • Anaemia (haemoglobin <7 mM)
  • Women treated with statins, corticosteroids or other hormone therapy ( except oestrogens and gestagens)
  • Ongoing abuse of alcohol or narcotics
  • Impaired renal function (se-creatinine > 120 μM and/or albuminuria)
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood presure > 100 mmHg)
  • Any condition that the investigator feels would interfere with trial participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795248

Locations
Denmark
Center for Diabetes Research
Hellerup, Denmark, 2900
Sponsors and Collaborators
Tina Vilsboll
Novo Nordisk A/S
Rigshospitalet, Denmark
Hvidovre University Hospital
Herlev Hospital
Hillerod Hospital, Denmark
University of Copenhagen
Investigators
Principal Investigator: Tina Vilsbøll, MD, DMSc University Hospital Gentofte
Principal Investigator: Signe Foghsgaard, MD, PhD University Hospital Gentofte
  More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tina Vilsboll, Dr. Tina Vilsbøll, DMSc, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01795248     History of Changes
Other Study ID Numbers: GDM-TREAT
2012-001371-37 ( EudraCT Number )
Study First Received: February 18, 2013
Last Updated: September 14, 2017

Keywords provided by Tina Vilsboll, University Hospital, Gentofte, Copenhagen:
gestational diabetes mellitus
incretin
glucose homeostasis
GLP-1
type 2 diabetes mellitus
liraglutide
Victoza

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 21, 2017