Type 1 DiabetesPhase 2NCT02898506
Incretin-based Therapy in Late Preclinical Type 1 Diabetes
A Phase 2 study testing Victoza® in people with Type 1 Diabetes, run by University of Oulu at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Victoza®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2016to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Finland3 sites
University of Oulu and Oulu University Hospital, Dept of Children and Adolescents
Oulu, 90029
University of Tampere and Tampere University Hospital
Tampere, 33520
University of Turku and Turku University Hospital
Turku, 20520
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Victoza®, Placebo
- Keywords
- Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue, Dysglycemia, Prevention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Victoza®Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza® Receives: Drug: Victoza® |
| Placebo | Placebo comparator | Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FPIR (1+3min serum insulin level after iv glucose infusion)
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
Measured: 12 months
Secondary outcomes (3)
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Measured: 12 months
Tolerability
Tolerability: frequency of side effects, hypoglycaemia and gastrointestinal symptoms in particular
Measured: 12 months
Serum C-peptide AUC
Serum C-peptide area under the curve (AUC) during 2-hour OGTT (oral glucose tolerance test)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, Tampere University Hospital, Turku University Hospital, Skane University Hospital
- Responsible party
- Principal investigator, Riitta Veijola, University of Oulu
- Investigators
- Riitta Veijola, MD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898506
- Sponsor's protocol ID
- LiraAABDG10-30
- Other IDs
- 2014-004761-25, U1111-1177-0704, 3-SRA-2014-301-M-R, 2014
- Status last verified
- Jan 2022
- First submitted
- 7 Sep 2016
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35797241
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incretin-based Therapy in Late Preclinical Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02898506
- Acronym / sponsor ID
- LiraAABDG10-30
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes Type 1, Diabetes, Insulin-Dependent, Liraglutide, Preclinical Type 1 Diabetes, GLP-1 Analogue, Dysglycemia, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital, Tampere University Hospital, Turku University Hospital, Skane University Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: Victoza®Subjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with Victoza® |
| Placebo | Placebo comparator | Drug: PlaceboSubjects with multiple islet autoantibodies and dysglycemia and aged 10-30 years are treated with placebo |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Liraglutide |
| PlaceboDaily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months. | Drug | Placebo |
Primary outcome
FPIR (1+3min serum insulin level after iv glucose infusion)
Time frame: 12 months
First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test)
3 secondary outcomes
Safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia
Time frame: 12 months
Tolerability
Time frame: 12 months
Serum C-peptide AUC
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 35797241Kero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riitta Veijola, MD principal investigator
University of Oulu
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Victoza® in people with Type 1 Diabetes, run by University of Oulu at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FPIR (1+3min serum insulin level after iv glucose infusion) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.