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

T

Tina Vilsboll

Status and phase

Completed
Phase 4

Conditions

Gestational Diabetes Mellitus

Treatments

Drug: Placebo
Drug: Liraglutide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01795248
GDM-TREAT
2012-001371-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

105 participants in 3 patient groups, including a placebo group

Liraglutide
Experimental group
Description:
1.8 mg liraglutide, subcutaneous, once-daily for five years
Treatment:
Drug: Liraglutide
Placebo
Placebo Comparator group
Description:
Placebo, subcutaneous, once-daily for one year
Treatment:
Drug: Placebo
Control
No Intervention group
Description:
Control without previous GDM.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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