HypoglycemiaNCT01739283
GIP and GLP-1 in Type 1 Diabetes
A study testing GIP, GLP-1 and Saline in people with Hypoglycemia, run by Mikkel Christensen at 1 site in Denmark.
Trial summary
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- GIP, GLP-1 and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2012to Nov 2013
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with type 1 diabetes (WHO criteria)
Who cannot join
- HbA1c > 9 %
- Liver disease (ALAT/ASAT > 2 x upper normal limit)
- Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III or IV)
- Anemia
- treatment with medication not applicable to pause for 12 hours
- C-peptide increase after 50 g iv arginine
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.
- Conditions
- Hypoglycemia
- Being tested
- GIP, GLP-1, Saline
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIPOther
GLP-1Other
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| hyperglycemia | Experimental | Hyperglycemic clamping Receives: Other: GIP; Other: Saline |
| hypoglycemia | Experimental | Hypoglycemic clamping Receives: Other: GIP; Other: GLP-1; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucagon area under curve values
Measured: approx. 15 minutes intervals, time 0 to 120 min
Secondary outcomes (1)
plasma gut hormones and nutrients (absolute, incremental and area under curve values)
Measured: approx. 15 minutes intervals, time 0 to 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionNov 2013
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 HypoglycemiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Christensen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Mikkel Christensen, University Hospital, Gentofte, Copenhagen
- Investigators
- Mikkel Christensen, MD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739283
- Sponsor's protocol ID
- H-2-2009-078 33269
- Status last verified
- Jul 2015
- First submitted
- 17 Nov 2012
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Christensen M, Calanna S, Sparre-Ulrich AH, Kristensen PL, Rosenkilde MM, Faber J, Purrello F, van Hall G, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide augments glucagon responses to hypoglycemia in type 1 diabetes. Diabetes. 2015 Jan;64(1):72-8. doi: 10.2337/db14-0440. Epub 2014 Jul 22.
PubMed 25053587
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIP and GLP-1 in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01739283
- Acronym / sponsor ID
- H-2-2009-078 33269
- Conditions
- Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mikkel ChristensenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Dec 2012 (estimated)
- 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.
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperglycemia | Experimental | Other: GIP, Other: SalineHyperglycemic clamping |
| hypoglycemia | Experimental | Other: GIP, Other: GLP-1, Other: SalineHypoglycemic clamping |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed with type 1 diabetes (WHO criteria)
Key exclusion criteria (8 listed)
- HbA1c > 9 %
- Liver disease (ALAT/ASAT > 2 x upper normal limit)
- Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III or IV)
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 |
|---|---|---|
| GIP | Other | hyperglycemia, hypoglycemia |
| GLP-1 | Other | hypoglycemia |
| Saline | Other | hyperglycemia, hypoglycemia |
Primary outcome
plasma glucagon area under curve values
Time frame: approx. 15 minutes intervals, time 0 to 120 min
1 secondary outcome
plasma gut hormones and nutrients (absolute, incremental and area under curve values)
Time frame: approx. 15 minutes intervals, time 0 to 120 min
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 13 Jul 2015.
- Derived from this study: PubMed 25053587Christensen M, Calanna S, Sparre-Ulrich AH, Kristensen PL, Rosenkilde MM, Faber J, Purrello F, van Hall G, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide augments glucagon responses to hypoglycemia in type 1 diabetes. Diabetes. 2015 Jan;64(1):72-8. doi: 10.2337/db14-0440. Epub 2014 Jul 22.
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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.
Mikkel Christensen, MD principal investigator
University Hospital, Gentofte, 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 GIP, GLP-1 and Saline in people with Hypoglycemia, run by Mikkel Christensen 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 1 inclusion and 8 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 13 Jul 2015. 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. 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 glucagon area under curve values (time frame: approx. 15 minutes intervals, time 0 to 120 min). 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 NCT01739283, 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 13 Jul 2015.