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Incretin-based Therapy in Early Diagnosed 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:
NCT02908087
First received: September 6, 2016
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Serum C-peptide AUC [ Time Frame: From baseline to 26 and 52 weeks ]
    Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)


Secondary Outcome Measures:
  • Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored [ Time Frame: From baseline to 26 and 52 weeks ]
    Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period

  • Number of hypoglycemia episodes [ Time Frame: From baseline to 26 and 52 weeks ]
    Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period

  • Frequency of gastrointestinal side effects [ Time Frame: 12 months ]
    Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period

  • Insulin dose [ Time Frame: From baseline to 26 and 52 weeks ]
    Insulin dose IU/kg/day


Estimated Enrollment: 10
Study Start Date: March 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Victoza® (liraglutide)
Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30 years, and treated with insulin are treated with Victoza®
Drug: Victoza® (liraglutide)
Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
Placebo Comparator: Placebo
Subjects with early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT) aged 10-30, and treated with insulin 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 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
  • early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
  • not pregnant.

Exclusion Criteria:

  • allergic to liraglutide or other ingredients of Victoza®
  • diabetic ketoacidosis
  • previous treatment in the last three months with any antidiabetic medication other than insulin
  • 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
  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: NCT02908087

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: NCT02908087     History of Changes
Other Study ID Numbers: LiraT1D10-30
2014-004760-37 ( EudraCT Number )
3-SRA-2014-301-M-R ( Other Grant/Funding Number: Juvenile Diabetes Research Foundation International )
U1111-1177-0661 ( Other Identifier: WHO )
Study First Received: September 6, 2016
Last Updated: September 15, 2016

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

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

ClinicalTrials.gov processed this record on September 18, 2017