NCT02351232

Brief Summary

A randomized placebo-controlled clinical trial investigating the effects of Liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 12, 2020

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

January 27, 2015

Last Update Submit

February 10, 2020

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Change in HbA1c from baseline to end of study (time 6 months)

    6 months

Secondary Outcomes (12)

  • Change in weight

    6 months

  • Change in insulin pump settings

    6 months

  • Change in glucose variability as measured by continuous glucose monitoring

    6 months

  • Change in body composition as measured by DXA-scan

    6 months

  • Change in blood pressure

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Liraglutide; daily subcutaneous injection; 1.8 mg; 6 months

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo; daily subcutaneous injection; 1.8 mg; 6 months

Drug: Placebo

Interventions

LiraglutideDRUG
Also known as: Victoza
Intervention
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes ≥ 1 year
  • BMI \> 25 kg/m2
  • Insulin pump ≥ 1 year
  • HbA1c \> 58 mmol/mol
  • Use of carbohydrate counting and the insulin pump bolus calculator

You may not qualify if:

  • Gastroparesis
  • Impaired renal function (eGFR \< 60 ml/min/1.73m2)
  • Liver disease with ALAT \> 2.5 times the upper limit of the reference interval
  • Acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis
  • Inflammatory bowel disease
  • History of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years
  • Thyroid adenoma
  • Subjects with personal or family history of MTC or MEN2
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Known or suspected alcohol or drug abuse
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
  • Simultaneous participation in any other clinical intervention trial
  • Known or suspected hypersensitivity to Liraglutide
  • Inability to understand the patient information and to give informed consent
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Dejgaard TF, Schmidt S, Frandsen CS, Vistisen D, Madsbad S, Andersen HU, Norgaard K. Liraglutide reduces hyperglycaemia and body weight in overweight, dysregulated insulin-pump-treated patients with type 1 diabetes: The Lira Pump trial-a randomized, double-blinded, placebo-controlled trial. Diabetes Obes Metab. 2020 Apr;22(4):492-500. doi: 10.1111/dom.13911. Epub 2019 Dec 19.

    PMID: 31696598RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kirsten Nørgaard, MD, DMSc

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 12, 2020

Record last verified: 2016-10

Locations

DK(2)