Type 2 DiabetesPhase 4CODI24NCT02089438
DPP-4 Inhibition, Incretins and Islet Function
A Phase 4 study testing Saxagliptin, Vildagliptin and Sitagliptin in people with Type 2 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Saxagliptin, Vildagliptin and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to Aug 2017
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion
- Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months
- Age 40-75 years
- HbA1c 52-80 mmol/mol (inclusive)
- BMI: 20-40 kg/m2
- Written informed consent has been given
- Capability and willingness to participate in the whole study
Who cannot join
- • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range
- Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
- Proliferative diabetic retinopathy
- Treatment with any glucose-lowering medication except metformin
- Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
- Symptomatic heart failure (NYHA class II-III)
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- Previous surgery on the gastrointestinal tract
- Larger surgical intervention during the last 12 weeks
- Female subject who are pregnant or breast feeding
- Women of child bearing potential not using a highly effective method of birth control
- Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
- Hypersensitivity to the active substances of to any of the excipients
- Participation in another study the last 4 weeks
- Smoker
- Paracetamol intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
Read the detailed description
The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
- Conditions
- Type 2 Diabetes
- Being tested
- Saxagliptin, Vildagliptin, Sitagliptin
- 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.
SaxagliptinDrug
Also called Onglyza
Saxagliptin (5 mg) is given before breakfast
VildagliptinDrug
Also called Galvus
Vildagliptin (50mg) is given before breakfast and dinner
SitagliptinDrug
Also called Januvia
Sitagliptin (100 mg) is given before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin | Experimental | Ssaxagliptin is given before breakfast Receives: Drug: Saxagliptin |
| ´Sitagliptin | Experimental | Sitagliptin is given before breakfast Receives: Drug: Sitagliptin |
| Vildagliptin | Experimental | Vildagliptin is given before breakfast Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
The area under the 180 min curves for plasma glucose after each meal
Measured: 180 min
Secondary outcomes (2)
Postprandial insulin and glucagon
The area under the 180 min curves for plasma insulin and glucagon after each meal
Measured: 180 min
Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
The area under the 180 min curves for plasma GLP-1 and GIP after each meal
Measured: 180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2017
- Study completionAug 2017
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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089438
- Sponsor's protocol ID
- 200A
- Acronym
- CODI24
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2014
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02089438
- Acronym / sponsor ID
- CODI24 / 200A
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Mar 2014 (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.
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
Detailed description
The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin | Experimental | Drug: SaxagliptinSsaxagliptin is given before breakfast |
| ´Sitagliptin | Experimental | Drug: SitagliptinSitagliptin is given before breakfast |
| Vildagliptin | Experimental | Drug: VildagliptinVildagliptin is given before breakfast |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion
Key exclusion criteria (15 listed)
- • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range
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 |
|---|---|---|
| SaxagliptinAlso: OnglyzaSaxagliptin (5 mg) is given before breakfast | Drug | Saxagliptin |
| VildagliptinAlso: GalvusVildagliptin (50mg) is given before breakfast and dinner | Drug | Vildagliptin |
| SitagliptinAlso: JanuviaSitagliptin (100 mg) is given before breakfast | Drug | ´Sitagliptin |
Primary outcome
Postprandial glucose
Time frame: 180 min
The area under the 180 min curves for plasma glucose after each meal
2 secondary outcomes
Postprandial insulin and glucagon
Time frame: 180 min
Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
Time frame: 180 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 23 Aug 2017.
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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 Saxagliptin, Vildagliptin and 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 7 inclusion and 15 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 23 Aug 2017. 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?
Postprandial glucose (time frame: 180 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 23 Aug 2017.