ClinicalTrials.gov
ClinicalTrials.gov Menu

Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults

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.
ClinicalTrials.gov Identifier: NCT02611232
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Information provided by (Responsible Party):
Riitta Veijola, University of Oulu

Brief Summary:
The main objectives of the trial are to study whether daily treatment with liraglutide improves insulin secretion and glucose metabolism, and whether liraglutide treatment is tolerable and safe in subjects with preclinical type 1 diabetes aged 18-30 years.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Victoza® Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults
Study Start Date : December 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Victoza®
Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza® (liraglutide)
Drug: Victoza®
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.

Placebo Comparator: Placebo
Subjects with preclinical type 1 diabetes aged 18-30 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. Duration of follow-up 24 months.




Primary Outcome Measures :
  1. FPIR (first phase insulin response) [ Time Frame: From baseline to 26 and 104 weeks ]
    First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )


Secondary Outcome Measures :
  1. Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia [ Time Frame: From baseline to 26 and 104 weeks ]
    Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia

  2. Tolerability [ Time Frame: From baseline to 26 and 104 weeks ]
    Tolerability: frequency of side effects

  3. Serum C-peptide AUC [ Time Frame: From baseline to 26 and 104 weeks ]
    Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-30 years of age
  • positive for at least 2 biochemical islet autoantibodies
  • have normal glucose tolerance in OGTT
  • are 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 ≥3.4pmol/l)
  • presence of any chronic metabolic, hematologic or malignant disease
  • obesity BMI ≥30
  • pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
  • breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611232


Locations
Finland
University of Oulu and Oulu University Hospital
Oulu, Finland, 90029
University of Tampere and Tampere University Hospital
Tampere, Finland, 33521
University of Turku and Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Tampere University Hospital
Turku University Hospital
Investigators
Principal Investigator: Riitta Veijola, MD University of Oulu

Responsible Party: Riitta Veijola, Professor, University of Oulu
ClinicalTrials.gov Identifier: NCT02611232     History of Changes
Other Study ID Numbers: LiraAAB18-30
2014-003667-37 ( EudraCT Number )
3-SRA-2014-301-M-R ( Other Grant/Funding Number: Juvenile Diabetes Research Foundation International )
U1111-1176-6062 ( Other Identifier: WHO )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

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

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