Type 2 DiabetesPhase 4SITACLAMPNCT02256189
Sitagliptin and Glucagon Counterregulation
A Phase 4 study testing Sitagliptin in people with Type 2 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written consent has been given.
- Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)
- Age >65 years.
- HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
- Ability to complete the study
Who cannot join
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Type 2 diabetes, positive GAD antibodies
- eGFR <60 ml/min
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
- Liver disease such as cirrhosis or chronic active hepatitis
Show all 10Show fewer
- History of coronary heart disease or heart failure class III or IV
- Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
Read the detailed description
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, Placebo
- 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.
SitagliptinDrug
Sitagliptin 100 mg daily
PlaceboDrug
Placebo one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin first, then placebo | Other | Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks Receives: Drug: Sitagliptin |
| Placebo first, then sitagliptin | Other | Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon Counterregulation to Hypoglycemia
Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo
Measured: Four weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 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 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
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Bo Ahren, Lund University
- Investigators
- Bo Ahrén, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256189
- Sponsor's protocol ID
- 300A
- Acronym
- SITACLAMP
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2014
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02256189
- Acronym / sponsor ID
- SITACLAMP / 300A
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
Detailed description
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin first, then placebo | Other | Drug: SitagliptinSitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks |
| Placebo first, then sitagliptin | Other | Drug: PlaceboPlacebo for four weeks, then washout for four weeks, then sitagliptin for four weeks |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Written consent has been given.
- Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)
- Age >65 years.
- HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
- Ability to complete the study
Key exclusion criteria (10 listed)
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Type 2 diabetes, positive GAD antibodies
- eGFR <60 ml/min
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
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 |
|---|---|---|
| SitagliptinSitagliptin 100 mg daily | Drug | Sitagliptin first, then placebo |
| PlaceboPlacebo one tablet daily | Drug | Placebo first, then sitagliptin |
Primary outcome
Glucagon Counterregulation to Hypoglycemia
Time frame: Four weeks treatment
Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD, PhD 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 Sitagliptin in people with Type 2 Diabetes, 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 5 inclusion and 10 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 20 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Counterregulation to Hypoglycemia (time frame: Four weeks treatment). 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 20 Feb 2019.