Type2 DiabetesNCT03845179
GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide
A study testing GIP receptor antagonist and DPP-4 inhibitor in people with Type2 Diabetes, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- GIP receptor antagonist and DPP-4 inhibitor
- Type of treatment
- Pill or oral medicine, 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
- 29 May 2019to 28 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes, treatment: lifestyle changes or metformin
- HbA1c < 75 mmol/mol
Who cannot join
- diagnosed liver disease
- eGFR < 60 ml/min/1,73m2
- NYHA III or IV
- anemia.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900
About this study
Official title: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide
This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.
Read the detailed description
A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.
- Conditions
- Type2 Diabetes
- Being tested
- Placebo, GIP receptor antagonist, DPP-4 inhibitor, Placebo tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Saline infusion
GIP receptor antagonistOther
Used for infusion on study days
DPP-4 inhibitorDrug
Also called Sitagliptin
Oral administration of DPP-4 inhibitor in active treatment period
Placebo tabletOther
Oral administration of placebo tablet in placebo treatment period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) Receives: Other: Placebo; Other: GIP receptor antagonist; Other: Placebo tablet |
| DPP-4 inhibitor | Active comparator | DPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) Receives: Other: Placebo; Other: GIP receptor antagonist; Drug: DPP-4 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide
Concentrations of C-peptide during GIP receptor antagonism compared to placebo
Measured: 5 hours
Secondary outcomes (7)
Plasma glucose
Concentrations of plasma glucose during GIP receptor antagonism compared to placebo
Measured: 5 hours
Insulin
Concentrations of insulin during GIP receptor antagonism compared to placebo
Measured: 5 hours
Total and intact GIP
Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo
Measured: 5 hours
Total and intact GLP-1
Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo
Measured: 5 hours
Glucagon
Concentrations of glucagon during GIP receptor antagonism compared to placebo
Measured: 5 hours
CTX
Concentrations of CTX during GIP receptor antagonism compared to placebo
Measured: 5 hours
Lipids
Concentrations of lipids during GIP receptor antagonism compared to placebo
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start29 May 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
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 Type2 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
- Model description
- Randomized, placebo-controlled, cross-over.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Stensen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845179
- Sponsor's protocol ID
- H-18040916
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsboll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in beta-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059.
PubMed 35796651
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide
- ClinicalTrials.gov ID
- NCT03845179
- Acronym / sponsor ID
- H-18040916
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 19 Feb 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.
This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.
Detailed description
A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, cross-over.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo, Other: GIP receptor antagonist, Other: Placebo tabletPlacebo tablet for placebo treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) |
| DPP-4 inhibitor | Active comparator | Other: Placebo, Other: GIP receptor antagonist, Drug: DPP-4 inhibitorDPP-4 inhibitor treatment for active treatment period. Following treatment: 2 separate interventions/study days (placebo infusion and GIP receptor antagonist) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- type 2 diabetes, treatment: lifestyle changes or metformin
- HbA1c < 75 mmol/mol
Key exclusion criteria (4 listed)
- diagnosed liver disease
- eGFR < 60 ml/min/1,73m2
- NYHA III or IV
- anemia.
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 |
|---|---|---|
| PlaceboSaline infusion | Other | DPP-4 inhibitor, Placebo |
| GIP receptor antagonistUsed for infusion on study days | Other | DPP-4 inhibitor, Placebo |
| DPP-4 inhibitorAlso: SitagliptinOral administration of DPP-4 inhibitor in active treatment period | Drug | DPP-4 inhibitor |
| Placebo tabletOral administration of placebo tablet in placebo treatment period | Other | Placebo |
Primary outcome
C-peptide
Time frame: 5 hours
Concentrations of C-peptide during GIP receptor antagonism compared to placebo
7 secondary outcomes
Plasma glucose
Time frame: 5 hours
Insulin
Time frame: 5 hours
Total and intact GIP
Time frame: 5 hours
Total and intact GLP-1
Time frame: 5 hours
Glucagon
Time frame: 5 hours
CTX
Time frame: 5 hours
Lipids
Time frame: 5 hours
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 16 Mar 2021.
- Derived from this study: PubMed 35796651Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsboll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in beta-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059.
- 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 GIP receptor antagonist and DPP-4 inhibitor in people with Type2 Diabetes, 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 2 inclusion and 4 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 16 Mar 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?
C-peptide (time frame: 5 hours). 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 NCT03845179, 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 16 Mar 2021.