Type 1 Diabetes MellitusPhase 2NCT02408705
Investigating the Effect of Liraglutide on the Endogenous Glucose Production During in Tye 1 Diabetes Subjects
A Phase 2 study testing Liraglutide and Mixed Meal Tolerance Test with paracetamol in people with Type 1 Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.
Trial summary
Each subject will be allocated to 2 periods of 3 months of once daily dosing with either liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive insulin treatment. Wash-out period between treatments will be 1 month. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Liraglutide and Mixed Meal Tolerance Test with paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to May 2016
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Type 1 diabetes mellitus as diagnosed (including I - III):
- history of type 1 diabetes mellitus manifestation with acute hyperglycaemia and ketonuria II. positive results for at least one of four islet antibodies (glutamic acid decarboxylase, protein tyrosine phosphatase, zinc transporter 8, or islet cell antibodies) III. residual basal fasting C-peptide of ≥ 0.1 nmol/L
- Male or female, aged 18 - 64 years (both inclusive)
- Body mass index (BMI) 20.0 - 25.0 kg/m2 (both inclusive)
- HbA1c 42 - 80 mmol/mol (6.0-9.5%)
- Treated with daily insulin injections or continuous s.c. insulin infusion (CSII) ≥ 1 months. Stable insulin dose as judged by the investigator
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products
- Use of liraglutide or exenatide within 3 months before screening
- Severe hypoglycaemia within 1 month of screening
- Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 2 months
- Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
- Aspartate transaminase(=AST), alanine aminotransferase (=ALT), lipase, alkaline phosphatase > 2.0 times upper limit of reference range (ULN)
Show all 17Show fewer
- Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count <3.0 x 109/L, thrombocytes <100 x 109/L
- Serum creatinine levels ≥ 126 μmol/L (male) or ≥ 111 μmol/L (female)
- Amylase outside normal range
- Screening calcitonin > 50 ng/L
- Personal history of non-familial medullary thyroid carcinoma
- History of chronic or idiopathic acute pancreatitis Suffer from or history of a life threatening disease (e.g. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the investigator.
- Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
- Any disease or condition that, in the opinion of the investigator, would represent an unacceptable risk for the subject's safety.
- Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator.
- Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive methods include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
- Severe acute and/or chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Two-period Cross-over Trial Investigating the Effect of Liraglutide as Add on to Intensive Insulin Treatment on the Endogenous Glucose Production in Subjects With C-peptide Positive Type 1 Diabetes Mellitus
Each subject will be allocated to 2 periods of 3 months of once daily dosing with either liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive insulin treatment. Wash-out period between treatments will be 1 month.
The trial can be divided into the following periods:
Read more
- Screening
- Treatment period 1
- Washout period
- Treatment period 2
- Follow up Visit
Mixed Meal Tolerance Test (MMTT) enriched with paracetamol:
At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol will be performed to assess the remaining beta-cell function via obtained maximal plasma C-peptide levels as well as the gastric emptying.
Experimental / Hypoglycaemic clamp :
At the end of each period (Visit 8, 15) a hypoglycaemic clamp will be performed. After the subject completed the MMTT on day 1, the subject will stay in the clinical unit to prepare for the hypoglycaemic clamp with an variable insulin infusion intravenously in order to obtain a steady state of a plasma glucose (PG) level of 5.5 mmol/L overnight until approximately 08:00. At 05:00 hours 10%-[6,6-2H2] glucose solution will be given i.v. as a primed (9.6mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last blood sampling of the plateau 4.0 mmol/L will be performed.
At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min for each subject and the PG will be kept at a plateau of 5.5 mmol/L by a controlled variable intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for one hour. Afterwards, PG is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of 2.5 mmol/L, then to a blood glucose of 4.0 mmol/L and finally back to a level of 5.5 mmol/L for safety reasons. Blood sampling for measurement of [6,6-2H2] glucose, glucagon, insulin, counterregulatory hormones, lactate, free fatty acids, glycerol, vital signs, hypoglycaemic symptoms questionnaire and hypoglycaemic awareness will be performed at each PG plateau.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Liraglutide, Placebo, Mixed Meal Tolerance Test with paracetamol
- Keywords
- Endogenous Glucose Production, Hypoglycemic clamp, Tracer to Tracee Technique, Type 1 diabetes mellitus
- 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.
LiraglutideDrug
Also called Victoza
They are receiving liraglutide for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks)
PlaceboDrug
They are receiving placebo for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks)
Mixed Meal Tolerance Test with paracetamolDrug
Also called MMTT
At the beginning and end of each period (Visit 2a, 8, 9a, 15) a Mixed Meal Tolerance Test enriched paracetamol will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Active comparator | 3-month treatment of liraglutide Receives: Drug: Liraglutide; Drug: Mixed Meal Tolerance Test with paracetamol |
| Placebo | Placebo comparator | 3-month treatment of placebo Receives: Drug: Placebo; Drug: Mixed Meal Tolerance Test with paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp 5.5 mmol/L period until the end of recovery period (4.0 mmol/L), calculated from stable isotope labelled plasma glucose
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Secondary outcomes (16)
Area under the curve of peripheral glucose uptake (=PGU), calculated from labelled PG from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Area under the glucose infusion rate curve from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean plasma glucagon concentrations from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of adrenaline from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of noradrenaline from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of cortisol from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of growth hormone from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Measured: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in number of regulatory T-cells detected by blood (fasting) and measured by a laboratory
Measured: After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)
Change in function of regulatory T-cells detected by blood (fasting) and measured by a laboratory
Measured: After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)
Area under the glucose curve during the Mixed Meal Tolerance Test
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the c-peptid concentration curve during the Mixed Meal Tolerance Test
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the paracetamol concentration curve to calculate gastric emptying during the Mixed Meal Tolerance Test
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the insulin curve during the Mixed Meal Tolerance Test
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the glucagon curve during the Mixed Meal Tolerance Test
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Change in HbA1c during each period detected by blood (fasting) at the begin of the visits and measured by a laboratory (tube: K3 EDTA Plasma)
Measured: Period 1: Visit 2a (Day 1) versus at Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Change in fasting plasma glucose during each period detected by blood at the begin of the visits and measured by a laboratory (tube: lithium heparin plasma)
Measured: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2016
- Study completionMay 2016
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Pieber Thomas, MD, Medical University of Graz
- Investigators
- Thomas R. Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408705
- Sponsor's protocol ID
- LG_T1_EGP
- Status last verified
- Sep 2016
- First submitted
- 28 Jan 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zenz S, Regittnig W, Boulgaropoulos B, Augustin T, Brunner M, Korsatko S, Munzker J, Narath SH, Raml R, Magnes C, Pieber TR. Effect of Liraglutide Treatment on Whole-body Glucose Fluxes in C-peptide-Positive Type 1 Diabetes During Hypoglycemia. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3583-e3593. doi: 10.1210/clinem/dgac369.
PubMed 35833597
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Two-period Cross-over Trial Investigating the Effect of Liraglutide as Add on to Intensive Insulin Treatment on the Endogenous Glucose Production in Subjects With C-peptide Positive Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02408705
- Acronym / sponsor ID
- LG_T1_EGP
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Endogenous Glucose Production, Hypoglycemic clamp, Tracer to Tracee Technique, Type 1 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Apr 2015 (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.
Each subject will be allocated to 2 periods of 3 months of once daily dosing with either liraglutide (1.2 mg) or placebo treatment (in random sequence) as add on to usual intensive insulin treatment. Wash-out period between treatments will be 1 month.
The trial can be divided into the following periods:
- Screening
- Treatment period 1
- Washout period
- Treatment period 2
- Follow up Visit
Mixed Meal Tolerance Test (MMTT) enriched with paracetamol:
At the beginning and end of each period a MMTT (Fortimel complete) enriched with paracetamol will be performed to assess the remaining beta-cell function via obtained maximal plasma C-peptide levels as well as the gastric emptying.
Experimental / Hypoglycaemic clamp :
At the end of each period (Visit 8, 15) a hypoglycaemic clamp will be performed. After the subject completed the MMTT on day 1, the subject will stay in the clinical unit to prepare for the hypoglycaemic clamp with an variable insulin infusion intravenously in order to obtain a steady state of a plasma glucose (PG) level of 5.5 mmol/L overnight until approximately 08:00. At 05:00 hours 10%-[6,6-2H2] glucose solution will be given i.v. as a primed (9.6mg/kg/min) for one minute and a constant (0.08 mg/kg/min) infusion until the last blood sampling of the plateau 4.0 mmol/L will be performed.
At 08:00 hours in the morning at day 2, insulin infusion will be increased to 1.5 mU/kg/min for each subject and the PG will be kept at a plateau of 5.5 mmol/L by a controlled variable intravenous infusion of glucose (10% glucose enriched with 4mg [6,6-2H2] glucose /ml) for one hour. Afterwards, PG is allowed to fall to a plateau of 3.5 mmol/L, then to a nadir of 2.5 mmol/L, then to a blood glucose of 4.0 mmol/L and finally back to a level of 5.5 mmol/L for safety reasons. Blood sampling for measurement of [6,6-2H2] glucose, glucagon, insulin, counterregulatory hormones, lactate, free fatty acids, glycerol, vital signs, hypoglycaemic symptoms questionnaire and hypoglycaemic awareness will be performed at each PG plateau.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Active comparator | Drug: Liraglutide, Drug: Mixed Meal Tolerance Test with paracetamol3-month treatment of liraglutide |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Mixed Meal Tolerance Test with paracetamol3-month treatment of placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Type 1 diabetes mellitus as diagnosed (including I - III):
- Male or female, aged 18 - 64 years (both inclusive)
- Body mass index (BMI) 20.0 - 25.0 kg/m2 (both inclusive)
- HbA1c 42 - 80 mmol/mol (6.0-9.5%)
Key exclusion criteria (17 listed)
- Known or suspected hypersensitivity to trial product(s) or related products
- Use of liraglutide or exenatide within 3 months before screening
- Severe hypoglycaemia within 1 month of screening
- Hypoglycaemia unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 2 months
- Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the investigator and any of the following laboratory safety results:
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 |
|---|---|---|
| LiraglutideAlso: VictozaThey are receiving liraglutide for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks) | Drug | Liraglutide |
| PlaceboThey are receiving placebo for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks) | Drug | Placebo |
| Mixed Meal Tolerance Test with paracetamolAlso: MMTTAt the beginning and end of each period (Visit 2a, 8, 9a, 15) a Mixed Meal Tolerance Test enriched paracetamol will be performed. | Drug | Liraglutide, Placebo |
Primary outcome
Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp 5.5 mmol/L period until the end of recovery period (4.0 mmol/L), calculated from stable isotope labelled plasma glucose
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
16 secondary outcomes
Area under the curve of peripheral glucose uptake (=PGU), calculated from labelled PG from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Area under the glucose infusion rate curve from begin of the hypoglycaemic clamp period 5.5mmol/L until end of recovery period (4.0 mmol/L)
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean plasma glucagon concentrations from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of adrenaline from begin of the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of noradrenaline from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of cortisol from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in mean values of growth hormone from begin the hypoglycaemic clamp period 5.5 mmol/L to 3.5 mmol/L to nadir and to recovery phase
Time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)
Change in number of regulatory T-cells detected by blood (fasting) and measured by a laboratory
Time frame: After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)
Change in function of regulatory T-cells detected by blood (fasting) and measured by a laboratory
Time frame: After 12 weeks and 2 days of treatment just before the hypoglycaemic clamp in each treatment period (day 86 and day 198)
Area under the glucose curve during the Mixed Meal Tolerance Test
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the c-peptid concentration curve during the Mixed Meal Tolerance Test
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the paracetamol concentration curve to calculate gastric emptying during the Mixed Meal Tolerance Test
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the insulin curve during the Mixed Meal Tolerance Test
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Area under the glucagon curve during the Mixed Meal Tolerance Test
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Change in HbA1c during each period detected by blood (fasting) at the begin of the visits and measured by a laboratory (tube: K3 EDTA Plasma)
Time frame: Period 1: Visit 2a (Day 1) versus at Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
Change in fasting plasma glucose during each period detected by blood at the begin of the visits and measured by a laboratory (tube: lithium heparin plasma)
Time frame: Period 1: Visit 2a (Day 1) versus Visit 8 (Day 85) ; Period 2: Visit 9a (Day 113) versus Visit 15 (Day 197)
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 12 Sep 2016.
- Derived from this study: PubMed 35833597Zenz S, Regittnig W, Boulgaropoulos B, Augustin T, Brunner M, Korsatko S, Munzker J, Narath SH, Raml R, Magnes C, Pieber TR. Effect of Liraglutide Treatment on Whole-body Glucose Fluxes in C-peptide-Positive Type 1 Diabetes During Hypoglycemia. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3583-e3593. doi: 10.1210/clinem/dgac369.
- Medical University of GrazLink provided by the sponsor.
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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.
Thomas R. Pieber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide and Mixed Meal Tolerance Test with paracetamol in people with Type 1 Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.
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 7 inclusion and 17 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 12 Sep 2016. 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 Austria. 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?
Area under the curve of the endogenous glucose production from (=EGP) from begin of the hypoglycaemic clamp 5.5 mmol/L period until the end of recovery period (4.0 mmol/L), calculated from stable isotope labelled plasma glucose (time frame: After 12 weeks and 2 days of treatment in each treatment period (day 86 and day 198)). 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 NCT02408705, 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 12 Sep 2016.