Type 2 Diabetes MellitusNCT03867656
Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
A study testing GLP-2 and GIP in people with Type 2 Diabetes Mellitus, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- GLP-2 and GIP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Feb 2019to 26 Jun 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 25 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age 25 to 70 years old.
- Type 2 diabetes.
- In Metformin or sulfonylureas
Who cannot join
- Treatment with other antidiabetics
- Osteopososis or gastrointestinal disease
- Smoking
- Long term steroid treatment
- Weight change more than 3 kg within the last 3 months.
- Overweight or intestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- GLP-2, GIP, Placebo
- Keywords
- Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover, Bone remodeling
- Medical subject headings
- Diabetes Mellitus, Type 2, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-2Other
GLP-2 injection
GIPOther
GIP injection
PlaceboOther
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| GLP-2 | Experimental | Glucagon-like peptide 2 Receives: Other: GLP-2 |
| GIP | Experimental | Glucose-dependent insulinotropic polypeptide Receives: Other: GIP |
| Placebo | Placebo comparator | Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTX
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
Measured: -10 minutes to 240 minutes
P1NP
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
Measured: -10 minutes to 240 minutes
Secondary outcomes (10)
PTH
PTH measured in serum
Measured: -10 minutes to 240 minutes
Sclerostin
Bone marker.
Measured: -10 min to 240 min.
Glucose
Measured in serum
Measured: -10 minutes to 240 minutes
Insulin
Measured in serum
Measured: -10 minutes to 240 minutes
C-peptide
Measured in serum
Measured: -10 minutes to 240 minutes
GIP
Glucose-dependent insulinotropic polypeptide measured in plasma.
Measured: -10 minutes to 240 minutes
GLP-2
Glucagon-like peptide 2 measured in plasma.
Measured: -10 minutes to 240 minutes
Glucagon
Glucagon measured in plasma
Measured: -10 minutes to 240 minutes
Blood pressure
Measured before blood sampling
Measured: -10 minutes to 240 minutes
Heart rate
Measured before blood sampling
Measured: -10 minutes to 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start26 Feb 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Kirsa Skov-Jeppesen, University of Copenhagen
- Investigators
- Mette Rosenkilde, MD, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867656
- Sponsor's protocol ID
- KS-4-Diabetes-19
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19
- ClinicalTrials.gov ID
- NCT03867656
- Acronym / sponsor ID
- KS-4-Diabetes-19
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Bone resorption, Bone formation, CTX, P1NP, GLP-2, GIP, Bone turnover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 8 Mar 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.
Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
| Arm | Type | Receives |
|---|---|---|
| GLP-2 | Experimental | Other: GLP-2Glucagon-like peptide 2 |
| GIP | Experimental | Other: GIPGlucose-dependent insulinotropic polypeptide |
| Placebo | Placebo comparator | Other: PlaceboSaline |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age 25 to 70 years old.
- Type 2 diabetes.
- In Metformin or sulfonylureas
Key exclusion criteria (6 listed)
- Treatment with other antidiabetics
- Osteopososis or gastrointestinal disease
- Smoking
- Long term steroid treatment
- Weight change more than 3 kg within the last 3 months.
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 |
|---|---|---|
| GLP-2GLP-2 injection | Other | GLP-2 |
| GIPGIP injection | Other | GIP |
| PlaceboPlacebo injection | Other | Placebo |
Primary outcome
CTX
Time frame: -10 minutes to 240 minutes
Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
P1NP
Time frame: -10 minutes to 240 minutes
Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.
10 secondary outcomes
PTH
Time frame: -10 minutes to 240 minutes
Sclerostin
Time frame: -10 min to 240 min.
Glucose
Time frame: -10 minutes to 240 minutes
Insulin
Time frame: -10 minutes to 240 minutes
C-peptide
Time frame: -10 minutes to 240 minutes
GIP
Time frame: -10 minutes to 240 minutes
GLP-2
Time frame: -10 minutes to 240 minutes
Glucagon
Time frame: -10 minutes to 240 minutes
Blood pressure
Time frame: -10 minutes to 240 minutes
Heart rate
Time frame: -10 minutes to 240 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 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Mette Rosenkilde, MD study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-2 and GIP in people with Type 2 Diabetes Mellitus, run by University of 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 4 inclusion and 6 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 Nov 2020. 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?
CTX (time frame: -10 minutes to 240 minutes). The study lists 2 primary outcomes in all. 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 4 Nov 2020.