Type 1 DiabetesGIPALANINNCT06881472
The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Subjects With and Without Type 1 Diabetes
A study testing Glucose-dependent Insulinotropic Polypeptide (GIP) and alanine in people with Type 1 Diabetes, run by Asger Lund, MD at 1 site in Denmark.
Trial summary
The hormone glucose-dependent insulinotropic polypeptide (GIP) is naturally produced in the intestine during a meal and stimulates insulin secretion from the pancreas. Insulin ensures that nutrients from the meal are transported from the blood into the cells, allowing the body to use it as energy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Glucose-dependent Insulinotropic Polypeptide (GIP) and alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2025to 16 Jan 2026
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian ethnicity
- Age between 18 and 70 years
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Body mass index between 20-27 kg/m2
- T1D duration of 2-20 years
- C-peptide negative (arginin-stimulated C-peptide ≤ 100 pmol/l)
- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
- Informed and written consent
Who cannot join
- Anaemia (haemoglobin below normal range)
- Late microvascular complications except mild nonproliferative retinopathy
- Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Treatment with any glucose-lowering drugs beside insulin
- Active or recent (within 5 years) malignant disease
- Active tobacco smoking / use
- Any condition considered incompatible with participation by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
The hormone glucose-dependent insulinotropic polypeptide (GIP) is naturally produced in the intestine during a meal and stimulates insulin secretion from the pancreas. Insulin ensures that nutrients from the meal are transported from the blood into the cells, allowing the body to use it as energy. If blood sugar levels drop too much, the body naturally releases another hormone: glucagon. Glucagon is responsible for the breakdown of nutrients inside the cells, thus causing blood sugar levels to rise again. This occurs, for example, when a person is fasting or in an energy deficit. Unfortunately, glucagon is not released in people with type 1 diabetes when blood sugar levels are low. However, it is known that GIP contributes to the secretion of glucagon during low blood sugar levels in both healthy individuals and those with type 1 diabetes.
Protein intake through the diet is broken down in the body into amino acids. It is known that the ingestion of protein and thus amino acids leads to an increase in glucagon in both healthy individuals and those with type 1 diabetes. This causes the amino acids to be converted into sugar, but also allows potentially harmful waste products from the breakdown to be converted into harmless components. The relationship between GIP and amino acids, as well as their joint effect on glucagon, is still unknown, but studies in mice have shown that if GIP and amino acids are given simultaneously, glucagon secretion will be even higher than if they were administered separately. The purpose of this study is to gain a better understanding of how the three (GIP, amino acids, and glucagon) are interconnected and affect each other and to see if the experiments conducted in mice yield the same results in healthy individuals and those with type 1 diabetes. Moreover, the secretion of glucagon, and thus the increase in blood sugar, might protect individuals with type 1 diabetes from experiencing low blood sugar. This knowledge could potentially be used for new treatment approaches in diabetes in the future.
- Conditions
- Type 1 Diabetes
- Being tested
- Glucose-dependent Insulinotropic Polypeptide (GIP), alanine, Saline (NaCl 0,9 %) (placebo)
- Keywords
- GIP, Amino acids, Alanine
- 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.
Glucose-dependent Insulinotropic Polypeptide (GIP)Drug
GIP
alanineDrug
Alanine
Saline (NaCl 0,9 %) (placebo)Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GIP | Active comparator | Not described Receives: Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Saline (NaCl 0,9 %) (placebo) |
| Alanine | Active comparator | Not described Receives: Drug: alanine; Drug: Saline (NaCl 0,9 %) (placebo) |
| GIP + Alanine | Active comparator | Not described Receives: Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: alanine |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bsAUC of glucagon concentration
Baseline Area under the curve of Glucagon concentration
Measured: From 0-150 minutes
Secondary outcomes (2)
bsAUC Glucagon 30-90
Baseline corrected area under the curve of time spend in hyoglycaemia
Measured: from 30-90 minutes
bsAUC glucagon 90-150 min
bs Glucagon in the recovery period
Measured: from 90-150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asger Lund, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881472
- Sponsor's protocol ID
- H-21066812-113790
- Acronym
- GIPALANIN
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Warnoe J, Thomas AM, Mathiesen DS, Preskou MK, Storling J, Christensen MB, Hartmann B, Holst JJ, Trammell SAJ, Campbell JE, Dejgaard TF, Lund AB, Knop FK, Gasbjerg LS. Additive Glucagonotropic and Insulinotropic Effects of Glucose-Dependent Insulinotropic Polypeptide and Alanine in Fasted Healthy Men. Diabetes Obes Metab. 2026 Sep 8. doi: 10.1111/dom.71273. Online ahead of print.
PubMed 42712058
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Subjects With and Without Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06881472
- Acronym / sponsor ID
- GIPALANIN / H-21066812-113790
- Conditions
- Type 1 Diabetes
- Keywords
- GIP, Amino acids, Alanine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Asger Lund, MDUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 18 Mar 2025 (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.
The hormone glucose-dependent insulinotropic polypeptide (GIP) is naturally produced in the intestine during a meal and stimulates insulin secretion from the pancreas. Insulin ensures that nutrients from the meal are transported from the blood into the cells, allowing the body to use it as energy. If blood sugar levels drop too much, the body naturally releases another hormone: glucagon. Glucagon is responsible for the breakdown of nutrients inside the cells, thus causing blood sugar levels to rise again. This occurs, for example, when a person is fasting or in an energy deficit. Unfortunately, glucagon is not released in people with type 1 diabetes when blood sugar levels are low. However, it is known that GIP contributes to the secretion of glucagon during low blood sugar levels in both healthy individuals and those with type 1 diabetes.
Protein intake through the diet is broken down in the body into amino acids. It is known that the ingestion of protein and thus amino acids leads to an increase in glucagon in both healthy individuals and those with type 1 diabetes. This causes the amino acids to be converted into sugar, but also allows potentially harmful waste products from the breakdown to be converted into harmless components. The relationship between GIP and amino acids, as well as their joint effect on glucagon, is still unknown, but studies in mice have shown that if GIP and amino acids are given simultaneously, glucagon secretion will be even higher than if they were administered separately. The purpose of this study is to gain a better understanding of how the three (GIP, amino acids, and glucagon) are interconnected and affect each other and to see if the experiments conducted in mice yield the same results in healthy individuals and those with type 1 diabetes. Moreover, the secretion of glucagon, and thus the increase in blood sugar, might protect individuals with type 1 diabetes from experiencing low blood sugar. This knowledge could potentially be used for new treatment approaches in diabetes in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIP | Active comparator | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: Saline (NaCl 0,9 %) (placebo) |
| Alanine | Active comparator | Drug: alanine, Drug: Saline (NaCl 0,9 %) (placebo) |
| GIP + Alanine | Active comparator | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: alanine |
| Placebo | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Caucasian ethnicity
- Age between 18 and 70 years
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Body mass index between 20-27 kg/m2
- T1D duration of 2-20 years
Key exclusion criteria (7 listed)
- Anaemia (haemoglobin below normal range)
- Late microvascular complications except mild nonproliferative retinopathy
- Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Treatment with any glucose-lowering drugs beside insulin
- Active or recent (within 5 years) malignant disease
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 |
|---|---|---|
| Glucose-dependent Insulinotropic Polypeptide (GIP)GIP | Drug | GIP, GIP + Alanine |
| alanineAlanine | Drug | Alanine, GIP + Alanine |
| Saline (NaCl 0,9 %) (placebo)Placebo | Drug | Alanine, GIP, Placebo |
Primary outcome
bsAUC of glucagon concentration
Time frame: From 0-150 minutes
Baseline Area under the curve of Glucagon concentration
2 secondary outcomes
bsAUC Glucagon 30-90
Time frame: from 30-90 minutes
bsAUC glucagon 90-150 min
Time frame: from 90-150 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 29 Apr 2026.
- Derived from this study: PubMed 42712058Warnoe J, Thomas AM, Mathiesen DS, Preskou MK, Storling J, Christensen MB, Hartmann B, Holst JJ, Trammell SAJ, Campbell JE, Dejgaard TF, Lund AB, Knop FK, Gasbjerg LS. Additive Glucagonotropic and Insulinotropic Effects of Glucose-Dependent Insulinotropic Polypeptide and Alanine in Fasted Healthy Men. Diabetes Obes Metab. 2026 Sep 8. doi: 10.1111/dom.71273. Online ahead of print.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Glucose-dependent Insulinotropic Polypeptide (GIP) and alanine in people with Type 1 Diabetes, run by Asger Lund, MD 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 8 inclusion and 7 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 29 Apr 2026. 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?
bsAUC of glucagon concentration (time frame: From 0-150 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 NCT06881472, 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 29 Apr 2026.