Diabetes Mellitus, Type 1NCT03556098
Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
A study testing glucose-dependent insulinotropic peptide, Glucose-Dependent Insulin-Releasing Hormone[3-30] and Saline Solution in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- glucose-dependent insulinotropic peptide, Glucose-Dependent Insulin-Releasing Hormone[3-30] and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Feb 2019to 11 Feb 2020
- 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 men
- Body mass index between 20-27 kg/m^2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c<69 mmol/l (<8,5%)
- T1D duration between 2-20 years
- Stimulated C-peptide ≤ 100 pmol/mL)
- Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
- Informed consent
Who cannot join
- Anemia (hemoglobin below normal range)
- Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Allergy or intolerance to ingredients included in the standardized meals
- Prior myocardial infarction or other cardiac events
- Any physical or psychological condition that the investigator fells would interfere with trial participation
- Treatment with any glucose-lowering drugs beside insulin
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology
Hellerup, 2900
About this study
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- glucose-dependent insulinotropic peptide, Glucose-Dependent Insulin-Releasing Hormone[3-30], Saline Solution
- Keywords
- Diabetes Mellitus, Type 1, Hypoglycemia, Gastric Inhibitory Polypeptide, Glucagon, Incretin
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose-dependent insulinotropic peptideDrug
Infusion of GIP
Glucose-Dependent Insulin-Releasing Hormone[3-30]Drug
Infusion of GIP antagonist GIP[3-30]
Saline SolutionDrug
Also called Placebo
Infusion of Saline
| Study group | Role | What they receive |
|---|---|---|
| GIP | Active comparator | Infusion of Glucose-dependent insulinotropic peptide Receives: Drug: glucose-dependent insulinotropic peptide |
| GIP[3-30] | Active comparator | Infusion of GIP[3-30] Receives: Drug: Glucose-Dependent Insulin-Releasing Hormone[3-30] |
| Saline | Placebo comparator | Infusion of saline Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucose concentration
plasma glucose excursions and plasma glucose nadir
Measured: At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days
Secondary outcomes (14)
Glucose regulatory hormones
Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Incretin hormones
Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
GIP[3-30]
GIP[3-30]. Incremental and total area under the Concentration-Time Curve
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Free fatty acids (FFA)
Free fatty acids(FFA). Incremental and total area under the Concentration-Time Curve
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Blood analysis of paracetamol as an assessment of gastric emptying
Assessment of gastric emptying
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Fat mRNA
Fat biopsy to evaluate changes in fat mRNA
Measured: At time 240 minute on study days
Fat Lipoprotein lipase (LPL)
Fat biopsy to evaluate LPL changes in fat
Measured: At time 240 minute on study days
Fat Perilipin 4
Fat biopsy to evaluate Perilipin 4 changes in fat
Measured: At time 240 minute on study days
Fat Fatty acid binding protein 4 (FABP4)
Fat biopsy to evaluate Fatty acid binding protein 4 (FABP4) changes in fat
Measured: At time 240 minute on study days
Fat Hormonse-sensitive lipase (HSL)
Fat biopsy to evaluate Hormonse-sensitive lipase (HSL) changes in fat
Measured: At time 240 minute on study days
Fat Vascular endothelial growth factor 4 (VEGF-A)
Fat biopsy to evaluate Vascular endothelial growth factor 4 (VEGF-A) changes in fat
Measured: At time 240 minute on study days
Fat GIP receptor (GIPR)
Fat biopsy to evaluate GIP receptor (GIPR) changes in fat
Measured: At time 240 minute on study days
Blood pressure
Changes in blood pressure, mm Hg
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Pulse
Changes in pulse, beats per minute
Measured: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start22 Feb 2019
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Double blinded, randomized, cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjørn Hoe, Steno Diabetes Center Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Study director, Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556098
- Sponsor's protocol ID
- H-18002707
- Status last verified
- May 2021
- First submitted
- 16 Apr 2018
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03556098
- Acronym / sponsor ID
- H-18002707
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Hypoglycemia, Gastric Inhibitory Polypeptide, Glucagon, Incretin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 14 Jun 2018 (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.
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in patients with T1D.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double blinded, randomized, cross-over study
| Arm | Type | Receives |
|---|---|---|
| GIP | Active comparator | Drug: glucose-dependent insulinotropic peptideInfusion of Glucose-dependent insulinotropic peptide |
| GIP[3-30] | Active comparator | Drug: Glucose-Dependent Insulin-Releasing Hormone[3-30]Infusion of GIP[3-30] |
| Saline | Placebo comparator | Drug: Saline SolutionInfusion of saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Caucasian men
- Body mass index between 20-27 kg/m^2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c<69 mmol/l (<8,5%)
- T1D duration between 2-20 years
- Stimulated C-peptide ≤ 100 pmol/mL)
Key exclusion criteria (7 listed)
- Anemia (hemoglobin below normal range)
- Liver disease (ALAT and/or ASAT >2 times normal values) or history of hepatobiliary disorder
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Allergy or intolerance to ingredients included in the standardized meals
- Prior myocardial infarction or other cardiac events
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 peptideInfusion of GIP | Drug | GIP |
| Glucose-Dependent Insulin-Releasing Hormone[3-30]Infusion of GIP antagonist GIP[3-30] | Drug | GIP[3-30] |
| Saline SolutionAlso: PlaceboInfusion of Saline | Drug | Saline |
Primary outcome
plasma glucose concentration
Time frame: At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days
plasma glucose excursions and plasma glucose nadir
14 secondary outcomes
Glucose regulatory hormones
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Incretin hormones
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
GIP[3-30]
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Free fatty acids (FFA)
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Blood analysis of paracetamol as an assessment of gastric emptying
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Fat mRNA
Time frame: At time 240 minute on study days
Fat Lipoprotein lipase (LPL)
Time frame: At time 240 minute on study days
Fat Perilipin 4
Time frame: At time 240 minute on study days
Fat Fatty acid binding protein 4 (FABP4)
Time frame: At time 240 minute on study days
Fat Hormonse-sensitive lipase (HSL)
Time frame: At time 240 minute on study days
Fat Vascular endothelial growth factor 4 (VEGF-A)
Time frame: At time 240 minute on study days
Fat GIP receptor (GIPR)
Time frame: At time 240 minute on study days
Blood pressure
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
Pulse
Time frame: At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days
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 10 May 2021.
- 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.
Filip K Knop, MD, PhD study director
Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology
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 peptide, Glucose-Dependent Insulin-Releasing Hormone[3-30] and Saline Solution in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center 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 7 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 10 May 2021. 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?
plasma glucose concentration (time frame: At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2021.