DiabetesPhase 4NCT01147276
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
A Phase 4 study testing Vildagliptin in people with Diabetes and Hypoglycemia, run by Lund University at 1 site in Sweden.
Trial summary
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Hypoglycemia
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Age >18 years
- HbA1c 6.5-8,5%
Who cannot join
- Pregnancy
- Lactation
- Acute infection
- Liver disease
- Treatment with cortisol
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences Lund, Lund University
Lund, 221 84
About this study
Official title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.
Read the detailed description
Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.
- Conditions
- Diabetes, Hypoglycemia
- Being tested
- Vildagliptin
- Keywords
- DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called Galvus
Vildagliptin (50 mg BID) in four weeks
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Vildagliptin (50 mg BID) given for four weeks Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon response to hypoglycemia
Change in glucagon from before hypoglycemic clamp until after 45 min
Measured: 45 min
Secondary outcomes (1)
Catecholamine response to hypoglycemic
Change in catecholamines from before hypolycemic clamp to 45 min
Measured: 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionDec 2011
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ahren, Lund University
- Investigators
- Bo Ahrén, PhD MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147276
- Sponsor's protocol ID
- Lund University Diabetes 002
- Status last verified
- Sep 2012
- First submitted
- 17 Jun 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farngren J, Persson M, Schweizer A, Foley JE, Ahren B. Vildagliptin reduces glucagon during hyperglycemia and sustains glucagon counterregulation during hypoglycemia in type 1 diabetes. J Clin Endocrinol Metab. 2012 Oct;97(10):3799-806. doi: 10.1210/jc.2012-2332. Epub 2012 Aug 1.
PubMed 22855332
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01147276
- Acronym / sponsor ID
- Lund University Diabetes 002
- Conditions
- Diabetes, Hypoglycemia
- Keywords
- DPP-4, GLP-1, Glucagon, Catecholamines, Counterregulation, Type 1 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jun 2010 (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.
The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.
Detailed description
Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: VildagliptinVildagliptin (50 mg BID) given for four weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Age >18 years
- HbA1c 6.5-8,5%
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation
- Acute infection
- Liver disease
- Treatment with cortisol
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 |
|---|---|---|
| VildagliptinAlso: GalvusVildagliptin (50 mg BID) in four weeks | Drug | Vildagliptin |
Primary outcome
Glucagon response to hypoglycemia
Time frame: 45 min
Change in glucagon from before hypoglycemic clamp until after 45 min
1 secondary outcome
Catecholamine response to hypoglycemic
Time frame: 45 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 25 Sep 2012.
- Derived from this study: PubMed 22855332Farngren J, Persson M, Schweizer A, Foley JE, Ahren B. Vildagliptin reduces glucagon during hyperglycemia and sustains glucagon counterregulation during hypoglycemia in type 1 diabetes. J Clin Endocrinol Metab. 2012 Oct;97(10):3799-806. doi: 10.1210/jc.2012-2332. Epub 2012 Aug 1.
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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.
Bo Ahrén, PhD MD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vildagliptin in people with Diabetes and Hypoglycemia, run by Lund University at 1 site in Sweden.
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 3 inclusion and 5 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 25 Sep 2012. 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 Sweden. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 response to hypoglycemia (time frame: 45 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 NCT01147276, 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 25 Sep 2012.