DiabetesPhase 3T1DMLIRANCT02092896
Liraglutide as add-on to Insulin in Type 1 Diabetes
A Phase 3 study testing Liraglutide in people with Diabetes and Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to: Part 1: To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to Oct 2014
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years
- BMI: 18-28
- HbA1c ≥ 8 %
- No residual β-cell function (glucagon test with c-peptide < 60 pM)
- Caucasian
- Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
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- Remission phase must be completed
- Female participants must use adequate contraception
- Informed consent
Who cannot join
- Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
- Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
- Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
- Pregnancy or lactation
- Epilepsy
- Use of antiepileptic medication
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- Use of beta blockers
- Previously apoplexy cerebri.
- Any use of benzodiazepine within the last month
- Any use of neuroleptic drugs within the last six months
- Self-perceived hearing loss
- Alcohol or drug abuse
- Allergy to the medication or placebo.
- Treatment with any medication affecting glucose metabolism.
- Any disorder which in the investigators opinion could interfere with the safety and results of the trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Endocrinology, Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
The purpose of this study is to:
Part 1:
To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.
Part 2:
To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- Liraglutide, Placebo
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Cognitive performance, Hypoglycemia, Insulin, Glucagon-Like Peptide 1, Hypoglycemic Agents, Physiological Effects of Drugs, Pharmacologic Actions, Incretins, Hormones
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
PlaceboDrug
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
LiraglutideDrug
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
PlaceboDrug
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Insulin + Study 2 | Placebo comparator | Study 2: Cognitive performance test Receives: Drug: Liraglutide |
| Liraglutide + Insulin + Study 2 | Experimental | Study 2: Cognitive performance test Receives: Drug: Placebo |
| Liraglutide + Insulin + Study 1 | Experimental | Study 1: Gastric emptying test Receives: Drug: Liraglutide |
| Placebo + Insulin + Study 1 | Placebo comparator | Study 1: Gastric emptying test Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c (glycosylated haemoglobin)
Measured: Week 0, week 12
Changes from baseline in EEG and cognitive performances
Measured: week 0, week 12
Change from baseline in gastric emptying rate
Measured: week 0, week 12
Secondary outcomes (7)
Change from baseline in glycemic control (CGM)
Measured: week 0, week 12
Change from baseline in total daily insulin dose
Measured: week 0, week 12
Changes from baseline in the counterregulatory hormone responses during hypoglycemia
Measured: week 0, week 12
Change from baseline in body weight
Measured: week 0, week 12
Change from baseline in auditory evoked potentials (AEP) during hypoglycemia
Measured: week 0, week 12
Change from baseline in corrected QTc-interval (QTc) during hypoglycemia
Measured: week 0, week 12
Change from baseline in hypoglycemic symptom score
Measured: week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionOct 2014
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NNF Center for Basal Metabolic Research, Denmark, Hillerod Hospital, Denmark, Danish PhD schools of Molecular Metabolism and Endocrinology, Novo Nordisk A/S
- Responsible party
- Principal investigator, Christan SS Frandsen, MD, Hvidovre University Hospital
- Investigators
- Christian SS Frandsen, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092896
- Sponsor's protocol ID
- 2012-002526-67
- Other IDs
- 2012-002526-67
- Acronym
- T1DMLIRA
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study. Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20.
PubMed 26486191
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
- ClinicalTrials.gov ID
- NCT02092896
- Acronym / sponsor ID
- T1DMLIRA / 2012-002526-67
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Cognitive performance, Hypoglycemia, Insulin, Glucagon-Like Peptide 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- NNF Center for Basal Metabolic Research, Denmark, Hillerod Hospital, Denmark, Danish PhD schools of Molecular Metabolism and Endocrinology, Novo Nordisk A/S
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Mar 2014 (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 purpose of this study is to:
Part 1:
To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.
Part 2:
To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo + Insulin + Study 2 | Placebo comparator | Drug: LiraglutideStudy 2: Cognitive performance test |
| Liraglutide + Insulin + Study 2 | Experimental | Drug: PlaceboStudy 2: Cognitive performance test |
| Liraglutide + Insulin + Study 1 | Experimental | Drug: LiraglutideStudy 1: Gastric emptying test |
| Placebo + Insulin + Study 1 | Placebo comparator | Drug: PlaceboStudy 1: Gastric emptying test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-70 years
- BMI: 18-28
- HbA1c ≥ 8 %
- No residual β-cell function (glucagon test with c-peptide < 60 pM)
- Caucasian
Key exclusion criteria (15 listed)
- Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
- Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
- Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
- Pregnancy or lactation
- Epilepsy
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 |
|---|---|---|
| LiraglutideSubjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed. | Drug | Liraglutide + Insulin + Study 1 |
| PlaceboSubjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed. | Drug | Placebo + Insulin + Study 1 |
| LiraglutideSubjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed. | Drug | Placebo + Insulin + Study 2 |
| PlaceboSubjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed. | Drug | Liraglutide + Insulin + Study 2 |
Primary outcome
Change from baseline in HbA1c (glycosylated haemoglobin)
Time frame: Week 0, week 12
Changes from baseline in EEG and cognitive performances
Time frame: week 0, week 12
Change from baseline in gastric emptying rate
Time frame: week 0, week 12
7 secondary outcomes
Change from baseline in glycemic control (CGM)
Time frame: week 0, week 12
Change from baseline in total daily insulin dose
Time frame: week 0, week 12
Changes from baseline in the counterregulatory hormone responses during hypoglycemia
Time frame: week 0, week 12
Change from baseline in body weight
Time frame: week 0, week 12
Change from baseline in auditory evoked potentials (AEP) during hypoglycemia
Time frame: week 0, week 12
Change from baseline in corrected QTc-interval (QTc) during hypoglycemia
Time frame: week 0, week 12
Change from baseline in hypoglycemic symptom score
Time frame: week 0, week 12
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 1 Apr 2015.
- Derived from this study: PubMed 26486191Frandsen CS, Dejgaard TF, Holst JJ, Andersen HU, Thorsteinsson B, Madsbad S. Twelve-Week Treatment With Liraglutide as Add-on to Insulin in Normal-Weight Patients With Poorly Controlled Type 1 Diabetes: A Randomized, Placebo-Controlled, Double-Blind Parallel Study. Diabetes Care. 2015 Dec;38(12):2250-7. doi: 10.2337/dc15-1037. Epub 2015 Oct 20.
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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.
Christian SS Frandsen, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide in people with Diabetes and Diabetes Mellitus, Type 1, run by Hvidovre University Hospital at 1 site in Denmark.
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 9 inclusion and 15 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in HbA1c (glycosylated haemoglobin) (time frame: Week 0, week 12). The study lists 3 primary outcomes in all. 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 NCT02092896, 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 1 Apr 2015.