Liraglutide in Type 1 Diabetes
1 other identifier
interventional
100
1 country
1
Brief Summary
A randomised, double-blind, placebo controlled study of the effect of liraglutide as an additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated type 1 diabetes patients. Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2 diabetes patients. It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight or poor glycaemic control (HbA1c \> 8 %). Small studies, not placebo controlled, reports effects of adding liraglutide to a group of well regulated (HbA1c \< 7.5 %) normal to overweight insulin treated type 1 diabetes patients for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured by continuous glucose monitoring was seen. Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy to insulin. Secondary objectives:To investigate the effect of liraglutide as an add-on therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences, meal test, CIMT, PWV and 24 hour blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJanuary 27, 2016
January 1, 2016
2.7 years
May 11, 2012
January 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
To investigate the effect of liraglutide 1.8 mg once daily compared to placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an adjunctive therapy to insulin treatment.
24 week
Secondary Outcomes (5)
Body weight
24 weeks
Cardiovascular
24 weeks
Standardised liquid meal test
24 weeks
Glycaemic excursions
24 weeks
Quality of life
24 weeks
Study Arms (2)
Liraglutide
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes according to WHO criteria ≥ 1 year
- Age ≥ 18 years
- BMI \> 25 kg/m2
- HbA1c \> 8.0 % at visit 0
You may not qualify if:
- Insulin pump treatment
- Hypoglycaemia unawareness (unability to register low blood glucose)
- Diabetic gastroparesis
- Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
- Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- Acute or chronic pancreatitis
- Inflammatory bowel disease
- Cancer unless in complete remission for \> 5 years
- History of thyroid adenoma or carcinoma
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using contraceptives
- Pregnant or nursing women
- Known or suspected hypersensitivity to trial product or related products
- Receipt of an investigational drug within 30 days prior to visit 0
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Steno Diabetes Center Copenhagenlead
- University Hospital, Gentofte, Copenhagencollaborator
- University of Copenhagencollaborator
Study Sites (1)
Steno Diabetes Center
Gentofte Municipality, 2820, Denmark
Related Publications (2)
Dejgaard TF, Frandsen CS, Hansen TS, Almdal T, Urhammer S, Pedersen-Bjergaard U, Jensen T, Jensen AK, Holst JJ, Tarnow L, Knop FK, Madsbad S, Andersen HU. Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):221-232. doi: 10.1016/S2213-8587(15)00436-2. Epub 2015 Dec 3.
PMID: 26656289DERIVEDDejgaard TF, Knop FK, Tarnow L, Frandsen CS, Hansen TS, Almdal T, Holst JJ, Madsbad S, Andersen HU. Efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide added to insulin therapy in poorly regulated patients with type 1 diabetes--a protocol for a randomised, double-blind, placebo-controlled study: the Lira-1 study. BMJ Open. 2015 Apr 2;5(4):e007791. doi: 10.1136/bmjopen-2015-007791.
PMID: 25838513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik U Andersen, DMSc
Steno Diabetes Center Copenhagen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor chief physician
Study Record Dates
First Submitted
May 11, 2012
First Posted
June 5, 2012
Study Start
June 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
January 27, 2016
Record last verified: 2016-01