Type 2 Diabetes MellitusEarly Phase 1GIP-HYPO-T2DMNCT01414556
GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
A Early Phase 1 study testing Glucose-dependent Insulinotropic polypeptide and saline in people with Type 2 Diabetes Mellitus, run by Mikkel Christensen at 1 site in Denmark.
Trial summary
Investigation of GIP effects at fasting and hypoglycemia Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glucose-dependent Insulinotropic polypeptide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Nov 2012
- Phase
- Early Phase 1
- 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
- Caucasians 18 years or older with Type 2 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 og IV)
- Anemia
- treatment with medication not applicable to pause for 12 hours
- Fasting plasma glucose >15 mM on screening day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Investigation of GIP effects at fasting and hypoglycemia
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glucose-dependent Insulinotropic polypeptide, saline
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-dependent Insulinotropic polypeptideOther
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
salineOther
| Study group | Role | What they receive |
|---|---|---|
| hyperglycemia | Experimental | Not described Receives: Other: Glucose-dependent Insulinotropic polypeptide; Other: saline |
| fasting glycemia | Experimental | Not described Receives: Other: Glucose-dependent Insulinotropic polypeptide; Other: saline |
| hypoglycemia | Experimental | Not described Receives: Other: Glucose-dependent Insulinotropic polypeptide; Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucagon/insulin(c-peptide) absolute, incremental and area under curve values
Measured: approx. 15 minutes intervals, time 0 to 120 min
Secondary outcomes (1)
plasma gut hormones and nutrients
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 posted11 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Christensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Christensen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414556
- Sponsor's protocol ID
- H-2-2009-078
- Acronym
- GIP-HYPO-T2DM
- Status last verified
- Mar 2013
- First submitted
- 5 Aug 2011
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
PubMed 31665480Christensen MB, Calanna S, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide: blood glucose stabilizing effects in patients with type 2 diabetes. J Clin Endocrinol Metab. 2014 Mar;99(3):E418-26. doi: 10.1210/jc.2013-3644. Epub 2013 Dec 11.
PubMed 24423311
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01414556
- Acronym / sponsor ID
- GIP-HYPO-T2DM / H-2-2009-078
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mikkel ChristensenUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Aug 2011 (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 GIP effects at fasting and hypoglycemia
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hyperglycemia | Experimental | Other: Glucose-dependent Insulinotropic polypeptide, Other: saline |
| fasting glycemia | Experimental | Other: Glucose-dependent Insulinotropic polypeptide, Other: saline |
| hypoglycemia | Experimental | Other: Glucose-dependent Insulinotropic polypeptide, Other: saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caucasians 18 years or older with Type 2 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 og 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 |
|---|---|---|
| Glucose-dependent Insulinotropic polypeptideinfusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min | Other | fasting glycemia, hyperglycemia, hypoglycemia |
| saline | Other | fasting glycemia, hyperglycemia, hypoglycemia |
Primary outcome
glucagon/insulin(c-peptide) absolute, incremental and area under curve values
Time frame: approx. 15 minutes intervals, time 0 to 120 min
1 secondary outcome
plasma gut hormones and nutrients
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 2 Apr 2013.
- Derived from this study: PubMed 31665480Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.
- Derived from this study: PubMed 24423311Christensen MB, Calanna S, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide: blood glucose stabilizing effects in patients with type 2 diabetes. J Clin Endocrinol Metab. 2014 Mar;99(3):E418-26. doi: 10.1210/jc.2013-3644. Epub 2013 Dec 11.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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 Early Phase 1 study testing Glucose-dependent Insulinotropic polypeptide and saline in people with Type 2 Diabetes Mellitus, 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 2 Apr 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
glucagon/insulin(c-peptide) absolute, incremental and 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 NCT01414556, which also lists 2 linked publications.
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 2 Apr 2013.