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. (see Contacts and Locations)
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
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

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
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014