Insulin SecretionPhase 4NCT01610154
Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
A Phase 4 study testing Sitagliptin in people with Insulin Secretion and Insulin Resistance, run by Guangwei Li at 1 site in China.
Trial summary
1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic. 2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI<25) and… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Insulin Secretion, Insulin Resistance
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Jun 2015
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 25~60 years
- Duration of disease < 3 years,no drug treatment for diabetes
- Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
- Fasting plasma glucose < 10 mmol/L
Who cannot join
- Type 1 diabetes
- DKA, infection and other stress status
- Autoimmune disease
- Hepatic and renal diseases
Trial locations and contacts
1 site in 1 country.
About this study
- The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
- There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI<25) and overweight (BMI>25) Chinese type 2 diabetics.
- The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.
- Conditions
- Insulin Secretion, Insulin Resistance
- Being tested
- Sitagliptin
- Keywords
- glucagon, dipeptidyl peptidase-4 inhibitor
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Sitagliptin 100 mg QD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin treatment | Experimental | Not described Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline to 12 weeks
Secondary outcomes (8)
Change From Baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline to 12 weeks
Change From Baseline in Postprandial Plasma Glucose (PPG)
Measured: Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Measured: Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity in Patients With Different BMI
The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.
Measured: Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Measured: Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
The early phase insulin response (△I30/△G30) was adopted to determine β cell function.
Measured: Baseline to 12 weeks
Change From Baseline in Pancreatic α Cell Function
The glucagon-AUC was adopted to show pancreatic α cell function.
Measured: Baseline to 12 weeks
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
The glucagon-AUC was adopted to show pancreatic α cell function.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionJun 2015
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 Insulin SecretionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangwei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guangwei Li, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610154
- Sponsor's protocol ID
- CIFuwaiHospital-MISP39889
- Status last verified
- Apr 2017
- First submitted
- 30 May 2012
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT01610154
- Acronym / sponsor ID
- CIFuwaiHospital-MISP39889
- Conditions
- Insulin Secretion, Insulin Resistance
- Keywords
- glucagon, dipeptidyl peptidase-4 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Guangwei LiUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
- There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI<25) and overweight (BMI>25) Chinese type 2 diabetics.
- The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin treatment | Experimental | Drug: Sitagliptin |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 25~60 years
- Duration of disease < 3 years,no drug treatment for diabetes
- Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h postprandial blood glucose>11.1mmol/L WHO 1999)
- Fasting plasma glucose < 10 mmol/L
Key exclusion criteria (4 listed)
- Type 1 diabetes
- DKA, infection and other stress status
- Autoimmune disease
- Hepatic and renal diseases
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 QD for 12 weeks | Drug | Sitagliptin treatment |
Primary outcome
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to 12 weeks
8 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline to 12 weeks
Change From Baseline in Postprandial Plasma Glucose (PPG)
Time frame: Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity
Time frame: Baseline to 12 weeks
Change From Baseline in Insulin Sensitivity in Patients With Different BMI
Time frame: Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function
Time frame: Baseline to 12 weeks
Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
Time frame: Baseline to 12 weeks
Change From Baseline in Pancreatic α Cell Function
Time frame: Baseline to 12 weeks
Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Insulin Secretion and Insulin Resistance, run by Guangwei Li 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 4 inclusion and 4 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 11 May 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 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). 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?
Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to 12 weeks). 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 11 May 2017.