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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
September 6, 2016
September 15, 2016
March 2016
July 2018   (Final data collection date for primary outcome measure)
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)
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes
  • 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.
  • 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.
  • 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®
    Intervention: Drug: Victoza® (liraglutide)
  • 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
    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
10
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
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
 
 
NCT02908087
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 )
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
September 2016

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