Gestational Diabetes MellitusPhase 4NCT01795248
The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes
A Phase 4 study testing Liraglutide in people with Gestational Diabetes Mellitus, run by Tina Vilsboll at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
- Women with known NAFLD or NASH
- Age >18 years
- 25 kg/m2 < BMI < 45 kg/m2
- NGT
- At least one prior pregnancy
Who cannot join
- 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
Show all 36Show fewer
- 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)
- 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
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, 2900
About this study
Official title: The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Liraglutide, Placebo
- Keywords
- gestational diabetes mellitus, incretin, glucose homeostasis, GLP-1, type 2 diabetes mellitus, liraglutide, Victoza
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza, NN2211
1.8 mg liraglutide
PlaceboDrug
Liraglutide without the GLP-1 analogue
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | 1.8 mg liraglutide, subcutaneous, once-daily for five years Receives: Drug: Liraglutide |
| Placebo | Placebo comparator | Placebo, subcutaneous, once-daily for one year Receives: Drug: Placebo |
| Control | No intervention | Control without previous GDM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
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)
Measured: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks
Secondary outcomes (1)
Deterioration in glycaemic status
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
Measured: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionSep 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tina Vilsboll
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Tina Vilsboll, University Hospital, Gentofte, Copenhagen
- Investigators
- Tina Vilsbøll, MD, DMSc, Principal investigator, University Hospital GentofteSigne Foghsgaard, MD, PhD, Principal investigator, University Hospital GentofteEmilie Skytte Andersen, MD, PhD-student, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795248
- Sponsor's protocol ID
- GDM-TREAT
- Other IDs
- 2012-001371-37
- Status last verified
- Nov 2020
- First submitted
- 18 Feb 2013
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10842653Vilsboll 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.
PubMed 14968296Vilsboll 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.
PubMed 16009062Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
PubMed 17928588Intensive 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.
PubMed 9742976Damm 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.
PubMed 8623813Jensen 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.
PubMed 14634573Metzger 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.
PubMed 9704245Lauenborg 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.
PubMed 15111544Xiang 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.
PubMed 20682697Hanna 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.
PubMed 12027921Bian 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.
PubMed 11776065Gerich 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.
PubMed 9715377Forbes 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.
PubMed 21153530Astrup 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.
PubMed 19853906
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01795248
- Acronym / sponsor ID
- GDM-TREAT
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, incretin, glucose homeostasis, GLP-1, type 2 diabetes mellitus, liraglutide, Victoza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tina VilsbollUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Copenhagen University Hospital, Rigshospitalet, Hvidovre University Hospital, Herlev Hospital, Hillerod Hospital, Denmark, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research, Aarhus University Hospital
- Study start
- Jul 2012 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: Liraglutide1.8 mg liraglutide, subcutaneous, once-daily for five years |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, subcutaneous, once-daily for one year |
| Control | No intervention | –Control without previous GDM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (36 listed)
- Patients with diabetes
- HbA1c ≥6.5%
- Patients with previous pancreatitis or previous neoplasia
- Pregnant or breast feeding women
- Anaemia (haemoglobin <7 mM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Victoza, NN22111.8 mg liraglutide | Drug | Liraglutide |
| PlaceboLiraglutide without the GLP-1 analogue | Drug | Placebo |
Primary outcome
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)
1 secondary outcome
Deterioration in glycaemic status
Time frame: from baseline to 52 wks, 53, wks, 260 wks, and 261 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 10842653Porte 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.
- Background: PubMed 14968296Vilsboll 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.
- Background: PubMed 16009062Vilsboll 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.
- Background: PubMed 17928588Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
- Background: PubMed 9742976Intensive 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.
- Background: PubMed 8623813Damm 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.
- Background: PubMed 14634573Jensen 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.
- Background: PubMed 9704245Metzger 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.
- Background: PubMed 15111544Lauenborg 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.
- Background: PubMed 20682697Xiang 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.
- Background: PubMed 12027921Hanna 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.
- Background: PubMed 11776065Bian 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.
- Main website for the University Hospital GentofteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Vilsbøll, MD, DMSc principal investigator
University Hospital Gentofte
Signe Foghsgaard, MD, PhD principal investigator
University Hospital Gentofte
Emilie Skytte Andersen, MD, PhD-student principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Gestational Diabetes Mellitus, run by Tina Vilsboll at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance (time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795248, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.