Type 2 DiabetesPhase 4NCT01660386
Study of Comparing the Different Effect of DPP-4 Inhibitors and Sulfonylurea by Using "Biphase-Hyperglycemic Clamp"
A Phase 4 study testing Sitagliptin, Saxagliptin and Glimepiride in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The objective of this study is to demonstrate the different effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the different effects of the study drugs on the GLP-1… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin, Saxagliptin and Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Mar 2013
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted;
- Having good study compliance;
- Healthy Male subjects between 20-30 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, and clinical laboratory test;
- Must have a body mass index (BMI) between 19-25kg/m2 (inclusive);
- No weight fluctuation greater than 5% in late 3 months。
Who cannot join
- With impaired glucose tolerance, T2DM or any significant medical condition (within 3 years), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;
- Used any prescribed systemic or topical medication within 30 days of the first dose administration;
- Any medical or surgical conditions possibly affecting study drug absorption, distribution, metabolism and excretion;
- Participated in a clinical study involving administration of an investigational drug within 90 days preceding the first dose administration or within five half-lives of the first dose administration (whichever is longer);
- Donated blood or plasma or had any other significant blood loss within 2 months preceding the first dose administration;
- History of multiple drug allergies;
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- Any clinically significant allergic disease;
- Recently drug or alcohol abuse (>35 unit/week, 1 unit=8g alcohol @ 1 standard drink @ 250ml beer @ 140ml wine @ 25ml strong alcohol drink like whiskey);
- Smokers or users of other tobacco products in the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine
Shanghai, 200021
Guang Ning, MD,PHD, +8621-64370045 ext. 665340, guangning@medmail.com.cn
Guang Ning, MD,PHD
About this study
Official title: An Open-label, Randomized, Four-way Cross-over, Single Dose Study to Compare the Different Effect of DPP-4 Inhibitors and Sulfonylurea on the Beta Cell Function by Using "Biphase-Hyperglycemic Clamp"
The objective of this study is to demonstrate the different effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the different effects of the study drugs on the GLP-1 response, and the glucagon concentration which indicates alpha cell function in healthy subjects.
Read the detailed description
After enrollment and two weeks screening period eligible subjects will be counseled to follow a dietary program for approximately 2 wk and recorded of personal history, full clinical examination and screening blood samples.
Subjects will be randomized using a computer-generated allocation schedule to one of 12 sequences during which each subjects will be assigned to take 4 times of bi-phase hyperglycaemic clamp experiments at a randomized sequence separated by a washout period of 7-14d.
At each experimental day, the subject will take the given dose of Sitagliptin, Saxagliptin, Glimepiride and nothing for blank control two hours before the clamp experiment starts.
The hyperglycaemic clamp will be performed after an overnight fast. Subjects will be placed in a recumbent position and cannula will be inserted in a dorsal hand vein. The hand will be placed in a heating box (42C) throughout the experiment to allow frequent sampling of arterialized blood. A second cannula will be inserted in a contralateral cubital vein for glucose infusion.
At time zero (0 min), a 50% glucose bolus will be injected during 1 min to increase PG to 12mM. The glucose bolus will be calculated as:(12mM-FPG)×35 mg glucose × body weight (kg). PG will be measured bedside every 5 min and maintained at 12mM by an adjustable continuous 20% glucose infusion. After 90min, PG will be lowered down below 6mM for the islet cells to rest, then the subject will be instructed to consume 75g glucose solution orally in 5min, PG will be measured bedside every 5 min and maintained below 6mM for 40min then restart the 90min-hyperglycaemic clamp experiment. The oral period of hyperglycaemic clamp process is the same as what's done in fasting period. Blood samples will be collected in -2h, 0min, 10min, 90min in both hyperglycaemic clamp experimental process for the measurement of insulin, C-peptide, glucagon, active GLP-1, total GLP-1 and DPP-4 activity.
Thus we could evaluate the beta cell function represented by the first phase and the second phase of insulin secretion(C-peptide secretion) and alpha cell function represented by the change of glucagon concentration during the fasting period and oral period of hyperglycaemic clamp experiment and the change of active GLP-1, total GLP-1 and DPP-4 activity as well.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, Saxagliptin, Glimepiride, Blank control
- Keywords
- Type 2 Diabetes, Dpp-4 inhibitor, Sulfonylurea, beta cell 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 Januvia
100mg po once
SaxagliptinDrug
Also called Onglyza
5mg po once
GlimepirideDrug
Also called Amaryl
2mg po once
Blank controlDrug
Also called Baseline
the subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | the subjects are asked to take one pill of sitagliptin(100mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. Receives: Drug: Sitagliptin |
| Saxagliptin | Experimental | the subjects are asked to take one pill of saxagliptin(5mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. Receives: Drug: Saxagliptin |
| Glimepiride | Experimental | the subjects are asked to take one pill of glimepiride(2mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. Receives: Drug: Glimepiride |
| Blank control | Other | the subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am. Receives: Drug: Blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acute phase and second phase of insulin secretion and C peptide secretion
The primary outcome measures are improvement in beta cell function measured as insulin secretion and C-peptide secretion during the bi-phase hyperglycaemic clamp. The first phase of insulin and C-peptide secretion is defined as the secretion between 0-10min, the second phase is defined as secretion between 20-90min of bi-phase hyperglycaemic clamp
Measured: 1-2 months
Secondary outcomes (1)
Alpha cell function,GLP-1 response
The secondary outcome measures are a relative increase in glucagon concentration which indicates alpha cell function and the GLP-1 response, DPP-4 activity and before taken the medicine and in 0, 10, 90,150,160,240min during the bi-phase hyperglycaemic clamp.
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
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 Shanghai Jiao Tong University School of MedicineThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD. PHD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660386
- Sponsor's protocol ID
- CCEMD014
- Status last verified
- Dec 2012
- First submitted
- 5 Aug 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Four-way Cross-over, Single Dose Study to Compare the Different Effect of DPP-4 Inhibitors and Sulfonylurea on the Beta Cell Function by Using "Biphase-Hyperglycemic Clamp"
- ClinicalTrials.gov ID
- NCT01660386
- Acronym / sponsor ID
- CCEMD014
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Dpp-4 inhibitor, Sulfonylurea, beta cell function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 8 Aug 2012 (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 objective of this study is to demonstrate the different effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the different effects of the study drugs on the GLP-1 response, and the glucagon concentration which indicates alpha cell function in healthy subjects.
Detailed description
After enrollment and two weeks screening period eligible subjects will be counseled to follow a dietary program for approximately 2 wk and recorded of personal history, full clinical examination and screening blood samples.
Subjects will be randomized using a computer-generated allocation schedule to one of 12 sequences during which each subjects will be assigned to take 4 times of bi-phase hyperglycaemic clamp experiments at a randomized sequence separated by a washout period of 7-14d.
At each experimental day, the subject will take the given dose of Sitagliptin, Saxagliptin, Glimepiride and nothing for blank control two hours before the clamp experiment starts.
The hyperglycaemic clamp will be performed after an overnight fast. Subjects will be placed in a recumbent position and cannula will be inserted in a dorsal hand vein. The hand will be placed in a heating box (42C) throughout the experiment to allow frequent sampling of arterialized blood. A second cannula will be inserted in a contralateral cubital vein for glucose infusion.
At time zero (0 min), a 50% glucose bolus will be injected during 1 min to increase PG to 12mM. The glucose bolus will be calculated as:(12mM-FPG)×35 mg glucose × body weight (kg). PG will be measured bedside every 5 min and maintained at 12mM by an adjustable continuous 20% glucose infusion. After 90min, PG will be lowered down below 6mM for the islet cells to rest, then the subject will be instructed to consume 75g glucose solution orally in 5min, PG will be measured bedside every 5 min and maintained below 6mM for 40min then restart the 90min-hyperglycaemic clamp experiment. The oral period of hyperglycaemic clamp process is the same as what's done in fasting period. Blood samples will be collected in -2h, 0min, 10min, 90min in both hyperglycaemic clamp experimental process for the measurement of insulin, C-peptide, glucagon, active GLP-1, total GLP-1 and DPP-4 activity.
Thus we could evaluate the beta cell function represented by the first phase and the second phase of insulin secretion(C-peptide secretion) and alpha cell function represented by the change of glucagon concentration during the fasting period and oral period of hyperglycaemic clamp experiment and the change of active GLP-1, total GLP-1 and DPP-4 activity as well.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: Sitagliptinthe subjects are asked to take one pill of sitagliptin(100mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. |
| Saxagliptin | Experimental | Drug: Saxagliptinthe subjects are asked to take one pill of saxagliptin(5mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. |
| Glimepiride | Experimental | Drug: Glimepiridethe subjects are asked to take one pill of glimepiride(2mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am. |
| Blank control | Other | Drug: Blank controlthe subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted;
- Having good study compliance;
- Healthy Male subjects between 20-30 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, and clinical laboratory test;
- Must have a body mass index (BMI) between 19-25kg/m2 (inclusive);
- No weight fluctuation greater than 5% in late 3 months。
Key exclusion criteria (9 listed)
- With impaired glucose tolerance, T2DM or any significant medical condition (within 3 years), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;
- Used any prescribed systemic or topical medication within 30 days of the first dose administration;
- Any medical or surgical conditions possibly affecting study drug absorption, distribution, metabolism and excretion;
- Participated in a clinical study involving administration of an investigational drug within 90 days preceding the first dose administration or within five half-lives of the first dose administration (whichever is longer);
- Donated blood or plasma or had any other significant blood loss within 2 months preceding the first dose administration;
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: Januvia100mg po once | Drug | Sitagliptin |
| SaxagliptinAlso: Onglyza5mg po once | Drug | Saxagliptin |
| GlimepirideAlso: Amaryl2mg po once | Drug | Glimepiride |
| Blank controlAlso: Baselinethe subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am. | Drug | Blank control |
Primary outcome
The acute phase and second phase of insulin secretion and C peptide secretion
Time frame: 1-2 months
The primary outcome measures are improvement in beta cell function measured as insulin secretion and C-peptide secretion during the bi-phase hyperglycaemic clamp. The first phase of insulin and C-peptide secretion is defined as the secretion between 0-10min, the second phase is defined as secretion between 20-90min of bi-phase hyperglycaemic clamp
1 secondary outcome
Alpha cell function,GLP-1 response
Time frame: 1-2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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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.
Guang Ning, MD. PHD principal investigator
Shanghai Jiao Tong University School of Medicine
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, Saxagliptin and Glimepiride in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 17 Dec 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, MD. PHD (+8621-64370045 ext. 665340, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acute phase and second phase of insulin secretion and C peptide secretion (time frame: 1-2 months). 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 17 Dec 2012.