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Incretin-based Therapy in Late Preclinical Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Skane University Hospital
Information provided by (Responsible Party):
Riitta Veijola, University of Oulu
ClinicalTrials.gov Identifier:
NCT02898506
First received: September 7, 2016
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Drug: Victoza® Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Riitta Veijola, University of Oulu:

Primary Outcome Measures:
  • FPIR [ Time Frame: 12 months ]
    First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 82
Study Start Date: March 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liraglutide
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®
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.
Placebo Comparator: Placebo
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo
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.

  Eligibility

Ages Eligible for Study:   10 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02898506

Locations
Finland
University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
Oulu, Finland, 90029
University of Tampere and Tampere University Hospital
Tampere, Finland, 33520
University of Turku and Turku University Hospital
Turku, Finland, 20520
Sweden
Lund University and Skåne University Hospital
Malmö, Sweden, 205 02
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Skane University Hospital
Investigators
Principal Investigator: Riitta Veijola, MD University of Oulu
  More Information

Responsible Party: Riitta Veijola, Professor, University of Oulu
ClinicalTrials.gov Identifier: NCT02898506     History of Changes
Other Study ID Numbers: 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 )
Study First Received: September 7, 2016
Last Updated: September 12, 2016

Keywords provided by Riitta Veijola, University of Oulu:
Diabetes Type 1
Diabetes, Insulin-Dependent
Liraglutide
Preclinical Type 1 Diabetes
GLP-1 Analogue
Dysglycemia
Prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liraglutide
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 21, 2017