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Incretin-based Therapy in Late Preclinical Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Victoza®
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue, Dysglycemia, Prevention

Eligibility Criteria

10 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
  • University of Tampere and Tampere University Hospital
  • University of Turku and Turku University Hospital
  • Lund University and Skåne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Liraglutide

Placebo

Arm Description

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®

Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo

Outcomes

Primary Outcome Measures

FPIR (1+3min serum insulin level after iv glucose infusion)
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
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Tolerability
Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular
Serum C-peptide AUC
Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)

Full Information

First Posted
September 7, 2016
Last Updated
January 7, 2022
Sponsor
University of Oulu
Collaborators
Oulu University Hospital, Tampere University Hospital, Turku University Hospital, Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02898506
Brief Title
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Official Title
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital, Tampere University Hospital, Turku University Hospital, Skane University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue, Dysglycemia, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza®
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo
Intervention Type
Drug
Intervention Name(s)
Victoza®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
FPIR (1+3min serum insulin level after iv glucose infusion)
Description
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Description
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Time Frame
12 months
Title
Tolerability
Description
Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular
Time Frame
12 months
Title
Serum C-peptide AUC
Description
Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riitta Veijola, MD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Facility Name
University of Tampere and Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
University of Turku and Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Lund University and Skåne University Hospital
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35797241
Citation
Kero J, Koskenniemi JJ, Karsikas S, Pokka T, Lou O, Toppari J, Veijola R. INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Diabet Med. 2022 Oct;39(10):e14913. doi: 10.1111/dme.14913. Epub 2022 Jul 22.
Results Reference
derived

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Incretin-based Therapy in Late Preclinical Type 1 Diabetes

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