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Completed

NCT Number: NCT02351232

The Lira Pump Trial

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Steno Diabetes Center, Gentofte Municipality, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
  • Any Cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.

Treatment and study plan

liraglutide

Drug

Other names: Victoza

Placebo

Drug

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

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

Secondary outcomes

  1. Change in weight

    Time frame: 6 months

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

  2. Change in insulin pump settings

    Time frame: 6 months

    Change in insulin pump settings from baseline to 3 weeks, 3 months and 6 months

  3. Change in glucose variability as measured by continuous glucose monitoring

    Time frame: 6 months

    Change in glucose variability from baseline to 3 weeks, 3 months and 6 months

  4. Change in body composition as measured by DXA-scan

    Time frame: 6 months

    Change in body composition from baseline to 6 months

  5. Change in blood pressure

    Time frame: 6 months

    Change in blood pressure from baseline to 6 months

  6. Change in lipid profile (LDL, HDL, VLDL, total cholesterol, triglycerides)

    Time frame: 6 months

    Change in lipid profile from baseline to 6 months

  7. Frequency of hypoglycemia (patient reported number of episodes with blood glucose <3.9 mmol/l)

    Time frame: 6 months

    Frequency of hypoglycemia during the 6-month study period

  8. Change in kidney function as measured by urine albumine/creatinine ratio

    Time frame: 6 months

    Change in kidney function from baseline to 6 months

  9. Number of daily blood glucose measurements

    Time frame: 6 months

    Number of daily blood glucose measurements during the 6-month study period

  10. Change in diet as measured by retrospective food recording

    Time frame: 6 months

    Change in dietary behavior from baseline to 3 and 6 months

  11. Change in treatment satisfaction as measured by Diabetes Treatment Satisfaction Questionnaire

    Time frame: 6 months

    Change in treatment satisfaction from baseline to 3 and 6 months

  12. Change in anxiety and depression as measured by Hospital Anxiety and Depression Scale

    Time frame: 6 months

    Change in anxiety and depression from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Steno Diabetes Center Copenhagen

Registry information

Official study title

The Lira Pump Trial. The Effects of Liraglutide in Patients With Insulin Pump Treated Type 1 Diabetes: A Randomized Placebo-Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2015
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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