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

NCT01795248 | Completed Phase 4

• 2 other identifiers: GDM-TREAT2012-001371-37
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

gestational diabetes mellitus; incretin; glucose homeostasis; GLP-1; type 2 diabetes mellitus; liraglutide; Victoza

Outcome Measures

Primary Outcomes (1)

• 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)

  from baseline to 52 wks, 53 wks, 260 wks, and 261 wks

Secondary Outcomes (1)

• Deterioration in glycaemic status

  from baseline to 52 wks, 53, wks, 260 wks, and 261 wks

Other Outcomes (16)

• Changes in glycated hemoglobin

  From baseline to 52 wks and 260 wks

• Changes in anthropometric measurements

  from baseline to 52 and 260 wks

• Changes in beta cell secretory responses

  from baseline to 52, 53, 260, and 261 wks

Study Arms (3)

Liraglutide

EXPERIMENTAL

1.8 mg liraglutide, subcutaneous, once-daily for five years

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo, subcutaneous, once-daily for one year

Drug: Placebo

Control

NO INTERVENTION

Control without previous GDM.

Interventions

Liraglutide DRUG

1.8 mg liraglutide

Also known as: Victoza, NN2211

Liraglutide

Placebo DRUG

Liraglutide without the GLP-1 analogue

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• kg/m2 \< BMI \< 45 kg/m2
• NGT, IFG and or IGT
• Safe contraception and negative pregnancy test

You may not qualify if:

• 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
• Informed oral and written consent

Sponsors & Collaborators

• Tina Vilsboll: lead
• Novo Nordisk A/S: collaborator
• Rigshospitalet, Denmark: collaborator
• Hvidovre University Hospital: collaborator
• Herlev Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator
• University of Copenhagen: collaborator
• The Novo Nordisk Foundation Center for Basic Metabolic Research: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen

Hellerup, 2900, Denmark

Location

Related Publications (19)

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  PMID: 15111544 BACKGROUND

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  PMID: 20682697 BACKGROUND

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  PMID: 12027921 BACKGROUND

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  PMID: 11776065 BACKGROUND

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  PMID: 9715377 BACKGROUND

• 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.

  PMID: 21153530 BACKGROUND

• 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.

  PMID: 19853906 BACKGROUND

• 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.

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• 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.

  PMID: 24176797 DERIVED

Related Links

• Main website for the University Hospital Gentofte

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Tina Vilsbøll, MD, DMSc

  University Hospital Gentofte

  PRINCIPAL INVESTIGATOR

• Signe Foghsgaard, MD, PhD

  University Hospital Gentofte

  PRINCIPAL INVESTIGATOR

• Emilie Skytte Andersen, MD, PhD-student

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Tina Vilsbøll, DMSc

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: July 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

DK (1)