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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

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ClinicalTrials.gov Identifier: NCT01795248
Recruitment Status : Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Novo Nordisk A/S
Rigshospitalet, Denmark
Hvidovre University Hospital
Herlev Hospital
Hillerod Hospital, Denmark
University of Copenhagen
The Novo Nordisk Foundation Center for Basic Metabolic Research
Aarhus University Hospital
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen

Tracking Information
First Submitted Date  ICMJE February 18, 2013
First Posted Date  ICMJE February 20, 2013
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 8, 2019)
  • 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 presence of non-alcoholic fatty liver disease (NAFLD) [ Time Frame: baseline to 52 and 260 wks ]
    gamma-glutamyltranferase (GGT), intra-heptic fat, FGF-21, whole body and visceral fat mass/fat-free mass, circulating lipids, ultrasound scan and fibroscan
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: February 18, 2013)
  • 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
  • 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 sensitivty 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 ]
  • Changes in subjective appetite [ Time Frame: baseline to 52, 53, 260, and 261 wks ]
  • Quality of life [ Time Frame: Baseline to 52 and 260 wks ]
 
Descriptive Information
Brief Title  ICMJE The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
Official Title  ICMJE The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Gestational Diabetes Mellitus
Intervention  ICMJE
  • Drug: Liraglutide
    1.8 mg liraglutide
    Other Names:
    • Victoza
    • NN2211
  • Drug: Placebo
    Liraglutide without the GLP-1 analogue
Study Arms  ICMJE
  • Experimental: Liraglutide
    1.8 mg liraglutide, subcutaneous, once-daily for five years
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo
    Placebo, subcutaneous, once-daily for one year
    Intervention: Drug: Placebo
  • No Intervention: Control
    Control without previous GDM.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 14, 2017)
105
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2013)
100
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01795248
Other Study ID Numbers  ICMJE GDM-TREAT
2012-001371-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tina Vilsboll, University Hospital, Gentofte, Copenhagen
Study Sponsor  ICMJE Tina Vilsboll
Collaborators  ICMJE
  • Novo Nordisk A/S
  • Rigshospitalet, Denmark
  • Hvidovre University Hospital
  • Herlev Hospital
  • Hillerod Hospital, Denmark
  • University of Copenhagen
  • The Novo Nordisk Foundation Center for Basic Metabolic Research
  • Aarhus University Hospital
Investigators  ICMJE
Principal Investigator: Tina Vilsbøll, MD, DMSc University Hospital Gentofte
Principal Investigator: Signe Foghsgaard, MD, PhD University Hospital Gentofte
Principal Investigator: Emilie Skytte Andersen, MD, PhD-student Steno Diabetes Center Copenhagen
PRS Account University Hospital, Gentofte, Copenhagen
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP