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Incretin-based Therapy in Late Preclinical Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02898506
First Posted: September 13, 2016
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Skane University Hospital
Information provided by (Responsible Party):
Riitta Veijola, University of Oulu
September 7, 2016
September 13, 2016
October 26, 2017
March 2016
July 2019   (Final data collection date for primary outcome measure)
FPIR [ Time Frame: 12 months ]
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
Same as current
Complete list of historical versions of study NCT02898506 on ClinicalTrials.gov Archive Site
  • Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia [ Time Frame: 12 months ]
    Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
  • Tolerability [ Time Frame: 12 months ]
    Tolerability: frequency of side effects
  • Serum C-peptide AUC [ Time Frame: 12 months ]
    Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
Same as current
Not Provided
Not Provided
 
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Type 1 Diabetes
  • Drug: Victoza®
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
  • Drug: Placebo
    Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
  • Active Comparator: Liraglutide
    Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®
    Intervention: Drug: Victoza®
  • Placebo Comparator: Placebo
    Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
82
July 2019
July 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 10-30 years of age
  • positive for at least 2 islet autoantibodies
  • glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT
  • not pregnant

Exclusion Criteria:

  • allergic to liraglutide or other ingredients of Victoza
  • type 1 diabetes
  • diabetic ketoacidosis
  • previous treatment in the last three months with any antidiabetic medication
  • impaired liver or kidney function or on dialysis
  • severe heart failure
  • severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
  • past or current history of pancreatitis
  • serum calcitonin value above normal (>50 ng/l or at least 3.4pmol/l)
  • presence of any chronic metabolic, hematologic or malignant disease
  • obesity BMI at least 30
  • pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
  • breast-feeding
Sexes Eligible for Study: All
10 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Sweden
 
 
NCT02898506
LiraAABDG10-30
2014-004761-25 ( EudraCT Number )
U1111-1177-0704 ( Other Identifier: WHO )
3-SRA-2014-301-M-R ( Other Grant/Funding Number: Juvenile Diabetes Research Foundation International )
Yes
Not Provided
Not Provided
Riitta Veijola, University of Oulu
University of Oulu
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Skane University Hospital
Principal Investigator: Riitta Veijola, MD University of Oulu
University of Oulu
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP