GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

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

The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Gestational Diabetes Mellitus

Lead sponsor

Tina Vilsboll

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

105

actual

Study population

Gestational diabetes, MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI ≤45•Female

Primary endpoint

•Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01795248

Org study IDGDM-TREAT

Secondary ID2012-001371-37

Timeline

Milestones

Study first posted2013-02-20estimated

Last update posted2020-11-04actual

Study start2012-07actual (month precision)

Primary completion2019-09actual (month precision)

Study completion2020-09actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Gestational diabetesMASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersAccepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

MASH / liver

Renal / kidney

Other clinical outcomes

Weight & body composition

1 endpoint

Other/protocol endpoint

Changes in anthropometric measurements

Time frame:from baseline to 52 and 260 wks

change from baseline, improvement

componentsBMI, change, Body weight, absolute change (kg), Waist circumference, change

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change in glucose tolerance

Time frame:from baseline to 52 wks, 53 wks, 260 wks, and 261 wks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Deterioration in glycaemic status

Time frame:from baseline to 52 wks, 53, wks, 260 wks, and 261 wks

threshold achievement, event

Other/protocol endpoint

Changes in glycated hemoglobin

Time frame:From baseline to 52 wks and 260 wks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Changes in beta cell secretory responses

Time frame:from baseline to 52, 53, 260, and 261 wks

change from baseline, improvement

Other/protocol endpoint

Changes in insulin sensitivity

Time frame:from baseline to 52, 53, 260, and 261 wks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint/low confidence

Changes in incretin hormone secretion

Time frame:baseline to 52, 53, 260, and 261 wks

change from baseline, improvement

componentsglp1 response, glp2 response, gip response, glucagon response

Other/protocol endpoint/low confidence

Changes in incretin effect

Time frame:baseline to 52, 53, 260, and 261 wks

change from baseline, improvement

MASH / liver

1 endpoint

Other/protocol endpoint/low confidence

Changes in presence of non-alcoholic fatty liver disease (NAFLD)

Time frame:baseline to 52 and 260 wks

categorical status, improvement

Renal / kidney

1 endpoint

Other/protocol endpoint

Evaluation of microalbuminuria

Time frame:baseline to 52 to 260 wks

categorical status, improvement

Patient-reported / QoL

2 endpoints

Other/protocol endpoint

Changes in subjective appetite

Time frame:baseline to 52, 53, 260, and 261 wks

change from baseline, improvement

Other/protocol endpoint

Change in Quality of life

Time frame:Baseline to 52 and 260 wks

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Number of participants with treatment-related adverse events (Safety and tolerability)

Time frame:baseline to 52 and 260 wks

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

Evaluation of blindedness of participants and investigators

Time frame:baseline to 52 wks

descriptive

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Evaluation of alcohol consumption

Time frame:baseline to 52 and 260 wks

Alcohol consumption, change

change from baseline, improvement

Other (unclassified)

3 endpoints

Other/protocol endpoint/low confidence

Changes in cardio-metabolic risk measures

Time frame:baseline to 52 and 260 wks

change from baseline, improvement

Other/protocol endpoint/low confidence

Changes in gut microbiota

Time frame:baseline to 52 and 260 wks

descriptive

Other/protocol endpoint/low confidence

Changes in bonemarkers

Time frame:baseline to 52 and 260 wks

change from baseline, improvement

Publications (19)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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 open2013 Oct 30PMID24176797doi:10.1136/bmjopen-2013-003834via clinicaltrials gov reference derived + pubmed nct search
Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.
International journal of obesity (2005)2012 Jun (month)PMID21844879doi:10.1038/ijo.2011.158via CT.gov background
Increased prevalence of non-alcoholic fatty liver disease in European women with a history of gestational diabetes.
Diabetologia2011 Mar (month)PMID21153530doi:10.1007/s00125-010-2009-0via CT.gov background
Detailed physiological characterization of the development of type 2 diabetes in Hispanic women with prior gestational diabetes mellitus.
Diabetes2010 Oct (month)PMID20682697doi:10.2337/db10-0521via CT.gov background
Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.
Lancet (London, England)2009 Nov 7PMID19853906doi:10.1016/S0140-6736(09)61375-1via CT.gov background
The physiology of glucagon-like peptide 1.
Physiological reviews2007 Oct (month)PMID17928588doi:10.1152/physrev.00034.2006via CT.gov background
On the role of the incretin hormones GIP and GLP-1 in the pathogenesis of Type 2 diabetes mellitus.
Danish medical bulletin2004 Nov (month)PMID16009062via CT.gov background
Increasing incidence of diabetes after gestational diabetes: a long-term follow-up in a Danish population.
Diabetes care2004 May (month)PMID15111544doi:10.2337/diacare.27.5.1194via CT.gov background
Incretins, insulin secretion and Type 2 diabetes mellitus.
Diabetologia2004 Mar (month)PMID14968296doi:10.1007/s00125-004-1342-6via CT.gov background
Screening for gestational diabetes mellitus by a model based on risk indicators: a prospective study.
American journal of obstetrics and gynecology2003 Nov (month)PMID14634573doi:10.1067/s0002-9378(03)00601-xvia CT.gov background
Screening for gestational diabetes; past, present and future.
Diabetic medicine : a journal of the British Diabetic Association2002 May (month)PMID12027921doi:10.1046/j.1464-5491.2002.00684.xvia CT.gov background
Risk factors for development of diabetes mellitus in women with a history of gestational diabetes mellitus.
Chinese medical journal2000 Aug (month)PMID11776065via CT.gov background
Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies.
International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity2000 Jan (month)PMID10702749doi:10.1038/sj.ijo.0801083via CT.gov background
Mechanisms for hyperglycemia in the metabolic syndrome. The key role of beta-cell dysfunction.
Annals of the New York Academy of Sciences1999 Nov 18PMID10842653doi:10.1111/j.1749-6632.1999.tb07786.xvia CT.gov background
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 (London, England)1998 Sep 12PMID9742976via CT.gov background
Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee.
Diabetes care1998 Aug (month)PMID9704245via CT.gov background
The genetic basis of type 2 diabetes mellitus: impaired insulin secretion versus impaired insulin sensitivity.
Endocrine reviews1998 Aug (month)PMID9715377doi:10.1210/edrv.19.4.0338via CT.gov background
Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans.
The Journal of clinical investigation1998 Feb 1PMID9449682doi:10.1172/JCI990via CT.gov background
Impaired insulin-stimulated nonoxidative glucose metabolism in glucose-tolerant women with previous gestational diabetes.
American journal of obstetrics and gynecology1996 Feb (month)PMID8623813doi:10.1016/s0002-9378(96)70456-8via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.