Diabetes After Total PancreatectomyPx-MealNCT04061473
Involvement of Dipeptidyl Peptidase-4 and Sodium-glucose Co-transporter-2 in Extrapancreatic Glucagon Secretion
A study testing Sitagliptin 100mg and Empagliflozin 25 MG in people with Diabetes After Total Pancreatectomy, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Glucagon is a 29-amino acid peptide hormone of essential importance for glucose homeostasis. Hitherto glucagon has been believed to be secreted only from the pancreas, but recent studies show that glucagon is also secreted from an extra pancreatic origin - most likely from enteroendocrine cells in the intestinal… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes After Total Pancreatectomy
- What is being tested?
- Sitagliptin 100mg and Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Apr 2019to 20 Aug 2019
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pancreatectomised patients
- Caucasian above 30 years of age who have undergone total pancreatectomy
- Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females
- Informed consent
- Non-diabetic control subjects
- Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria)
Show all 9Show fewer
- Normal blood haemoglobin
- Caucasian above 30 years of age
- Informed consent
Who cannot join
- Pancreatectomised patients
- Pancreatectomy within the last 3 months
- Ongoing chemotherapy or chemotherapy within the last 3 months
- Treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors within the last 3 months
- eGFR<60 ml/min/1,73m2 and/or albuminuria
- Known liver disease (excluding simple steatosis) and/or serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 × upper normal limit)
Show all 19Show fewer
- Pregnancy and/or breastfeeding
- Age above 85 years
- Uncontrolled hypertension and/or significant cardiovascular disease
- Any condition that the investigator feels would interfere with trial participation
- Non-diabetic control subjects
- Diabetes or prediabetes (according to WHO criteria)
- First-degree relatives with diabetes
- eGFR<60 ml/min/1,73m2 and/or albuminuria
- Known liver disease (excluding simple steatosis) and/or serum ALAT and/or serum ASAT >3 × upper normal limits)
- Pregnancy and/or breastfeeding
- Age above 85 years
- Uncontrolled hypertension and/or significant cardiovascular disease
- Any condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research
Hellerup, Capital Region, 2900
About this study
Glucagon is a 29-amino acid peptide hormone of essential importance for glucose homeostasis. Hitherto glucagon has been believed to be secreted only from the pancreas, but recent studies show that glucagon is also secreted from an extra pancreatic origin - most likely from enteroendocrine cells in the intestinal epithelium (Baekdal et al., unpublished data). This has fundamentally changed the understanding of glucagon physiology and provides new avenues for the investigation of several metabolic disorders in which hyperglucagonaemia represents a common and important pathophysiological characteristic (including type 2 diabetes). To delineate the physiological role of gut-derived glucagon and its potential pathophysiological implications, and thereby clear the way for new treatment modalities targeting gut glucagon, it is of importance to understand how glucagon secretion from the gut is regulated. In contrast to the regulation of pancreatic glucagon secretion, very little is known about the regulation of gut-derived glucagon.
Inhibition of the enzyme dipeptidyl peptidase 4 (DPP-4) which under normal circumstances degrades, and thereby inactivates the two gut-derived incretin hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1), has been shown to decrease pancreatic glucagon secretion. This is most likely brought about by increased levels of intact, active GLP-1, which is known to suppress pancreatic glucagon secretion. Furthermore, the sodium-glucose transporter 2 (SGLT-2) seems to be implicated in pancreatic glucagon secretion as inhibitors of SGLT-2 have been shown to increase the secretion of pancreatic glucagon secretion.
Read more
The present project will employ further investigations of totally pancreatectomised patients to delineate the regulation of gut-derived glucagon secretion with focus on the well-known modulators of pancreatic glucagon secretion, the enzyme DPP-4 and the sodium-glucose co-transporter SGLT-2, respectively.
The study is designed as a randomised, double-blinded, crossover study. 10 healthy persons and 10 totally pancreatectomized patients will be subjected to 3 experimental days. All participants will undergo a screening visit and three experimental days (day A (meal test during DPP-4 inhibition), B (meal test during SGLT-2 inhibition) and C (meal test with placebo)). A liquid meal test will be followed by a fasting period and finished off with an ad libitum meal.
- Conditions
- Diabetes After Total Pancreatectomy
- Being tested
- Sitagliptin 100mg, Empagliflozin 25 MG, Placebo tablet
- Keywords
- Pancreatectomy, Diabetes, SGLT-2 inhibitor, DPP4 inhibitor, glucagon
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin 100mgDrug
2 tablets of sitagliptin 100 mg.
Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
Empagliflozin 25 MGDrug
2 tablets of empagliflozin 25 mg.
Placebo tabletOther
2 placebo tablets.
Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatectomized + Placebo | Placebo comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
Before the meal (1 h and 12 h) 1+1 placebo tablets will be administered orally. Receives: Other: Placebo tablet |
| Pancreatectomized + DPP-4 inhibitor | Active comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
Before the meal (1 h and 12 h) 1+1 DPP4-inhibitor tablets will be administered orally. Receives: Drug: Sitagliptin 100mg |
| Pancreatectomized + SGLT-2 inhibitor | Active comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol.
Before the meal (1 h and 12 h) 1+1 SGLT-2 tablets will be administred orally. Receives: Drug: Empagliflozin 25 MG |
| Healthy + Placebo | Placebo comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Receives: Other: Placebo tablet |
| Healthy + DPP-4 inhibitor | Active comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Receives: Drug: Sitagliptin 100mg |
| Healthy + SGLT-2 inhibitor | Active comparator | During the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Receives: Drug: Empagliflozin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucagon excursions measured as incremental area under the curve (iAUC)
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Secondary outcomes (11)
PPG excurions measured as incremental area under the curve (iAUC)
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
endogenous glucose production
Using intravenous and oral tracers
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
GLP-1, gastrin, cholecystokinin, GIP, oxyntomodulin
excurions measured as incremental area under the curve (iAUC)
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Differences in gastric emptying, meassurement of s-paracetamol
measurement of time to peak and incremental area under the curve (iAUC)
Measured: -120-180 minutes
satiety, appetite, thirst,
assesed by a visual analougue scale (VAS)
Measured: -30, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Resting energy expenditure (REE)
measured by indirect calorimetry
Measured: -90, 150 and 150 minutes
p-glucose mmol/L
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
s-peptide pmol/l
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
s-insulin
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Pulse and blood pressure
will be measured every 30th min
Measured: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
food intake
the ad libitum meal will be weighed before after ingestion.
Measured: 180 and 210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start2 Apr 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
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 Diabetes After Total PancreatectomyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is designed as a randomised, double-blinded, crossover study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061473
- Sponsor's protocol ID
- H-19000992
- Acronym
- Px-Meal
- Status last verified
- Sep 2019
- First submitted
- 15 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baekdal M, Nielsen SW, Hansen CP, Storkholm JH, van Hall G, Hartmann B, Holst JJ, Vilsboll T, Lund A, Knop FK. Empagliflozin Normalizes Fasting Hyperglycemia and Improves Postprandial Glucose Tolerance in Totally Pancreatectomized Patients: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Diabetes Care. 2024 Jan 1;47(1):71-80. doi: 10.2337/dc23-0645.
PubMed 37703527
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Dipeptidyl Peptidase-4 and Sodium-glucose Co-transporter-2 in Extrapancreatic Glucagon Secretion
- ClinicalTrials.gov ID
- NCT04061473
- Acronym / sponsor ID
- Px-Meal / H-19000992
- Conditions
- Diabetes After Total Pancreatectomy
- Keywords
- Pancreatectomy, Diabetes, SGLT-2 inhibitor, DPP4 inhibitor, glucagon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 19 Aug 2019 (actual)
- 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.
Glucagon is a 29-amino acid peptide hormone of essential importance for glucose homeostasis. Hitherto glucagon has been believed to be secreted only from the pancreas, but recent studies show that glucagon is also secreted from an extra pancreatic origin - most likely from enteroendocrine cells in the intestinal epithelium (Baekdal et al., unpublished data). This has fundamentally changed the understanding of glucagon physiology and provides new avenues for the investigation of several metabolic disorders in which hyperglucagonaemia represents a common and important pathophysiological characteristic (including type 2 diabetes). To delineate the physiological role of gut-derived glucagon and its potential pathophysiological implications, and thereby clear the way for new treatment modalities targeting gut glucagon, it is of importance to understand how glucagon secretion from the gut is regulated. In contrast to the regulation of pancreatic glucagon secretion, very little is known about the regulation of gut-derived glucagon.
Inhibition of the enzyme dipeptidyl peptidase 4 (DPP-4) which under normal circumstances degrades, and thereby inactivates the two gut-derived incretin hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1), has been shown to decrease pancreatic glucagon secretion. This is most likely brought about by increased levels of intact, active GLP-1, which is known to suppress pancreatic glucagon secretion. Furthermore, the sodium-glucose transporter 2 (SGLT-2) seems to be implicated in pancreatic glucagon secretion as inhibitors of SGLT-2 have been shown to increase the secretion of pancreatic glucagon secretion.
The present project will employ further investigations of totally pancreatectomised patients to delineate the regulation of gut-derived glucagon secretion with focus on the well-known modulators of pancreatic glucagon secretion, the enzyme DPP-4 and the sodium-glucose co-transporter SGLT-2, respectively.
The study is designed as a randomised, double-blinded, crossover study. 10 healthy persons and 10 totally pancreatectomized patients will be subjected to 3 experimental days. All participants will undergo a screening visit and three experimental days (day A (meal test during DPP-4 inhibition), B (meal test during SGLT-2 inhibition) and C (meal test with placebo)). A liquid meal test will be followed by a fasting period and finished off with an ad libitum meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- The study is designed as a randomised, double-blinded, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Pancreatectomized + Placebo | Placebo comparator | Other: Placebo tabletDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Before the meal (1 h and 12 h) 1+1 placebo tablets will be administered orally. |
| Pancreatectomized + DPP-4 inhibitor | Active comparator | Drug: Sitagliptin 100mgDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Before the meal (1 h and 12 h) 1+1 DPP4-inhibitor tablets will be administered orally. |
| Pancreatectomized + SGLT-2 inhibitor | Active comparator | Drug: Empagliflozin 25 MGDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. Before the meal (1 h and 12 h) 1+1 SGLT-2 tablets will be administred orally. |
| Healthy + Placebo | Placebo comparator | Other: Placebo tabletDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. |
| Healthy + DPP-4 inhibitor | Active comparator | Drug: Sitagliptin 100mgDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. |
| Healthy + SGLT-2 inhibitor | Active comparator | Drug: Empagliflozin 25 MGDuring the experimental day the participant will ingest a standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pancreatectomised patients
- Caucasian above 30 years of age who have undergone total pancreatectomy
- Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females
- Informed consent
- Non-diabetic control subjects
Key exclusion criteria (19 listed)
- Pancreatectomised patients
- Pancreatectomy within the last 3 months
- Ongoing chemotherapy or chemotherapy within the last 3 months
- Treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors within the last 3 months
- eGFR<60 ml/min/1,73m2 and/or albuminuria
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 |
|---|---|---|
| Sitagliptin 100mg2 tablets of sitagliptin 100 mg. Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. | Drug | Healthy + DPP-4 inhibitor, Pancreatectomized + DPP-4 inhibitor |
| Empagliflozin 25 MG2 tablets of empagliflozin 25 mg. | Drug | Healthy + SGLT-2 inhibitor, Pancreatectomized + SGLT-2 inhibitor |
| Placebo tablet2 placebo tablets. Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol. | Other | Healthy + Placebo, Pancreatectomized + Placebo |
Primary outcome
glucagon excursions measured as incremental area under the curve (iAUC)
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
11 secondary outcomes
PPG excurions measured as incremental area under the curve (iAUC)
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
endogenous glucose production
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
GLP-1, gastrin, cholecystokinin, GIP, oxyntomodulin
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Differences in gastric emptying, meassurement of s-paracetamol
Time frame: -120-180 minutes
satiety, appetite, thirst,
Time frame: -30, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Resting energy expenditure (REE)
Time frame: -90, 150 and 150 minutes
p-glucose mmol/L
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
s-peptide pmol/l
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
s-insulin
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
Pulse and blood pressure
Time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes
food intake
Time frame: 180 and 210 minutes
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 4 Sep 2019.
- Derived from this study: PubMed 37703527Baekdal M, Nielsen SW, Hansen CP, Storkholm JH, van Hall G, Hartmann B, Holst JJ, Vilsboll T, Lund A, Knop FK. Empagliflozin Normalizes Fasting Hyperglycemia and Improves Postprandial Glucose Tolerance in Totally Pancreatectomized Patients: A Randomized, Double-Blind, Placebo-Controlled Crossover Study. Diabetes Care. 2024 Jan 1;47(1):71-80. doi: 10.2337/dc23-0645.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitagliptin 100mg and Empagliflozin 25 MG in people with Diabetes After Total Pancreatectomy, run by University Hospital, Gentofte, Copenhagen 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 19 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 4 Sep 2019. 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.
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?
glucagon excursions measured as incremental area under the curve (iAUC) (time frame: -120, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes). 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 NCT04061473, 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 4 Sep 2019.