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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborators:
Novo Nordisk A/S
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Tina Vilsboll, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01795248
First received: February 18, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    assessed by HOMA-IR and Matsuda insulin sensitivty index

  • Changes in incretin hormone secretion [ Time Frame: baseline to 52, 53, 260, and 261 wks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    insulin and c-peptide responses after OGTT vs. IIGI

  • Changes in cardio-metabolic risk measures [ Time Frame: baseline to 52 and 260 wks ] [ Designated as safety issue: Yes ]
  • Changes in subjective appetite [ Time Frame: baseline to 52, 53, 260, and 261 wks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: baseline to 52 and 260 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Primary Completion Date: July 2018 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795248

Contacts
Contact: Signe Foghsgaard, MD +4539772058 Signe.Foghsgaard@regionh.dk
Contact: Louise Vedtofte, M.Sc., PhD +4539772688 Louise.Vedtofte@regionh.dk

Locations
Denmark
Diabetology Research Unit Recruiting
Hellerup, Denmark, 2900
Contact: Signe Foghsgaard, MD    +4539772058    Signe.Foghsgaard@regionh.dk   
Contact: Louise Vedtofte, M.Sc., PhD    +4539772688    Louise.Vedtofte@regionh.dk   
Sub-Investigator: Signe Foghsgaard, MD         
Sub-Investigator: Louise Vedtofte, M.Sc., PhD         
Sub-Investigator: Filip K Knop, MD, PhD         
Sponsors and Collaborators
Tina Vilsboll
Novo Nordisk A/S
Rigshospitalet, Denmark
Investigators
Principal Investigator: Tina Vilsbøll, MD, DMSc University Hospital Gentofte
  More Information

Additional Information:
Publications:

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
Study First Received: February 18, 2013
Last Updated: February 18, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by 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
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014