Type 2 DiabetesNCT01901861
Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes
A study testing Sitagliptin in people with Type 2 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg). Read more about this study
- Who is it for?
- Ages 20 to 75 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2013to Dec 2015
- 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 20 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian men with type 2 diabetes diagnosed according to ICD10
- Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily
- Age 20-75 years
- HbA1c ≤80 mmol/mol
- BMI: 20-40 kg/m2
Who cannot join
- Liver disease or ALAT three times above upper reference range
- Diabetic nephropathy (GFR < 50 mL/min/1.73 m2 or albuminuria)
- Proliferative diabetic retinopathy
- Treatment with any glucose-lowering medication except metformin
- Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
- Previous surgery on the gastrointestinal tract
Show all 12Show fewer
- Larger surgical intervention during the last 12 weeks
- Treatment with oral steroids or thiazide diuretics
- Treatment with digoxin
- Smokers
- Participation in another study the last 4 weeks
- Paracetamol intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Dose of the DPP-4 Inhibitor on Islet Function After Igestion of a Standardized Mixed Meal in Subjects With Type 2 Diabetes
study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).
Read the detailed description
In men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, Placebo
- Keywords
- GLP-1, GIP, DPP-4 inhibition, iset function
- 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
Also called Mixed meal test with sitagliptin
Sitagliptin 100mg is given before meal ingestion
PlaceboDrug
Also called Mixed meal test with placebo
Placebo is given before meal ingestion
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Sitagliptin 100mg is given before meal ingestion Receives: Drug: Sitagliptin |
| Placebo | Placebo comparator | Placebo is given before meal ingestion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Release of incretins hormones
Measured: 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 12 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 Ahren, Professor, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901861
- Sponsor's protocol ID
- 2012-005660-98
- Status last verified
- Mar 2015
- First submitted
- 14 Jul 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Dose of the DPP-4 Inhibitor on Islet Function After Igestion of a Standardized Mixed Meal in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01901861
- Acronym / sponsor ID
- 2012-005660-98
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1, GIP, DPP-4 inhibition, iset function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jul 2013 (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.
study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).
Detailed description
In men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: SitagliptinSitagliptin 100mg is given before meal ingestion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is given before meal ingestion |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caucasian men with type 2 diabetes diagnosed according to ICD10
- Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily
- Age 20-75 years
- HbA1c ≤80 mmol/mol
- BMI: 20-40 kg/m2
Key exclusion criteria (12 listed)
- Liver disease or ALAT three times above upper reference range
- Diabetic nephropathy (GFR < 50 mL/min/1.73 m2 or albuminuria)
- Proliferative diabetic retinopathy
- Treatment with any glucose-lowering medication except metformin
- Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 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 |
|---|---|---|
| SitagliptinAlso: Mixed meal test with sitagliptinSitagliptin 100mg is given before meal ingestion | Drug | Sitagliptin |
| PlaceboAlso: Mixed meal test with placeboPlacebo is given before meal ingestion | Drug | Placebo |
Primary outcome
Release of incretins hormones
Time frame: 300 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 15 Dec 2015.
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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 Ahren, Professor 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 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 12 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 15 Dec 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 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. 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?
Release of incretins hormones (time frame: 300 min). 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 15 Dec 2015.