The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
NCT ID: NCT01795248
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2012-07-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Liraglutide
1.8 mg liraglutide, subcutaneous, once-daily for five years
Liraglutide
1.8 mg liraglutide
Placebo
Placebo, subcutaneous, once-daily for one year
Placebo
Liraglutide without the GLP-1 analogue
Control
Control without previous GDM.
No interventions assigned to this group
Interventions
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Liraglutide
1.8 mg liraglutide
Placebo
Liraglutide without the GLP-1 analogue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* Pregnant or breast feeding women
* Anaemia (haemoglobin \<7 mM)
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Rigshospitalet, Denmark
OTHER
Hvidovre University Hospital
OTHER
Herlev Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
University of Copenhagen
OTHER
The Novo Nordisk Foundation Center for Basic Metabolic Research
OTHER
Aarhus University Hospital
OTHER
Tina Vilsboll
OTHER
Responsible Party
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Tina Vilsboll
Dr. Tina Vilsbøll, DMSc
Principal Investigators
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Tina Vilsbøll, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
University Hospital Gentofte
Signe Foghsgaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Gentofte
Emilie Skytte Andersen, MD, PhD-student
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, , Denmark
Countries
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References
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Porte D Jr. Mechanisms for hyperglycemia in the metabolic syndrome. The key role of beta-cell dysfunction. Ann N Y Acad Sci. 1999 Nov 18;892:73-83. doi: 10.1111/j.1749-6632.1999.tb07786.x.
Vilsboll T, Holst JJ. Incretins, insulin secretion and Type 2 diabetes mellitus. Diabetologia. 2004 Mar;47(3):357-366. doi: 10.1007/s00125-004-1342-6. Epub 2004 Feb 13.
Vilsboll T. On the role of the incretin hormones GIP and GLP-1 in the pathogenesis of Type 2 diabetes mellitus. Dan Med Bull. 2004 Nov;51(4):364-70. No abstract available.
Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
Damm P, Vestergaard H, Kuhl C, Pedersen O. Impaired insulin-stimulated nonoxidative glucose metabolism in glucose-tolerant women with previous gestational diabetes. Am J Obstet Gynecol. 1996 Feb;174(2):722-9. doi: 10.1016/s0002-9378(96)70456-8.
Jensen DM, Molsted-Pedersen L, Beck-Nielsen H, Westergaard JG, Ovesen P, Damm P. Screening for gestational diabetes mellitus by a model based on risk indicators: a prospective study. Am J Obstet Gynecol. 2003 Nov;189(5):1383-8. doi: 10.1067/s0002-9378(03)00601-x.
Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
Lauenborg J, Hansen T, Jensen DM, Vestergaard H, Molsted-Pedersen L, Hornnes P, Locht H, Pedersen O, Damm P. Increasing incidence of diabetes after gestational diabetes: a long-term follow-up in a Danish population. Diabetes Care. 2004 May;27(5):1194-9. doi: 10.2337/diacare.27.5.1194.
Xiang AH, Kjos SL, Takayanagi M, Trigo E, Buchanan TA. Detailed physiological characterization of the development of type 2 diabetes in Hispanic women with prior gestational diabetes mellitus. Diabetes. 2010 Oct;59(10):2625-30. doi: 10.2337/db10-0521. Epub 2010 Aug 3.
Hanna FW, Peters JR. Screening for gestational diabetes; past, present and future. Diabet Med. 2002 May;19(5):351-8. doi: 10.1046/j.1464-5491.2002.00684.x.
Bian X, Gao P, Xiong X, Xu H, Qian M, Liu S. Risk factors for development of diabetes mellitus in women with a history of gestational diabetes mellitus. Chin Med J (Engl). 2000 Aug;113(8):759-62.
Gerich JE. The genetic basis of type 2 diabetes mellitus: impaired insulin secretion versus impaired insulin sensitivity. Endocr Rev. 1998 Aug;19(4):491-503. doi: 10.1210/edrv.19.4.0338.
Forbes S, Taylor-Robinson SD, Patel N, Allan P, Walker BR, Johnston DG. Increased prevalence of non-alcoholic fatty liver disease in European women with a history of gestational diabetes. Diabetologia. 2011 Mar;54(3):641-7. doi: 10.1007/s00125-010-2009-0. Epub 2010 Dec 12.
Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.
Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.
Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 1;101(3):515-20. doi: 10.1172/JCI990.
Foghsgaard S, Vedtofte L, Mathiesen ER, Svare JA, Gluud LL, Holst JJ, Damm P, Knop FK, Vilsboll T. The effect of a glucagon-like peptide-1 receptor agonist on glucose tolerance in women with previous gestational diabetes mellitus: protocol for an investigator-initiated, randomised, placebo-controlled, double-blinded, parallel intervention trial. BMJ Open. 2013 Oct 30;3(10):e003834. doi: 10.1136/bmjopen-2013-003834.
Related Links
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Main website for the University Hospital Gentofte
Other Identifiers
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2012-001371-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GDM-TREAT
Identifier Type: -
Identifier Source: org_study_id