Type 2 DiabetesPhase 4T2DMRSNCT02129985
Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy
A Phase 4 study testing Exenatide and Metformin in people with Type 2 Diabetes, run by xiaolong zhao at 1 site in China.
Trial summary
Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Sep 2015
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed type 2 diabetes without drug treatment
- 25-70 years old age
- Fasting glucose between 7.0-16.7mmol / L
- BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
- females who have no plan of pregnancy during the study
Who cannot join
- acute or chronic complications of diabetes
- myocardial infarction or cerebrovascular events within three months
- serious gastrointestinal diseases
- other serious concomitant diseases
- liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
- GAD antibodies positive
Show all 10Show fewer
- history of pancreatitis or pancreatic cancer;
- pregnant or breastfeeding women.
- severe hypertension (blood pressure> 180/110mmhg)
- using corticosteroids, immunosuppressants and cytotoxic therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaolong Zhao
Jingan, Shanghai Municipality, 20041
xiaolong zhao, MD., 86-18918067241, xiaolongzhao@163.com
xiaolong zhao, MD.
About this study
Official title: Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study
Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.
Read the detailed description
The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus,irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.Short-term intensive insulin therapy of newly diagnosed type 2 diabetes has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is an GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide, Metformin
- Keywords
- the newly onset type 2 diabetes, short-term insulin treatment, exenatide sequential therapy, beta cell function, glycaemic remission
- 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.
ExenatideDrug
Also called GLP-1 receptor agonist
Exenatide (10 ug/bid for 3 months)
MetforminDrug
Also called Glucophage
Metformin 850 mg/bid for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | patients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months) Receives: Drug: Exenatide |
| Metformin | Active comparator | patients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months) Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to glycaemic remission
time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment
Measured: up to 1 year
remission rate of type 2 diabetes at a year.
remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy
Measured: up to 1 year
Secondary outcomes (1)
the beta cell function change
the beta cell function change expressed by the ratio of proinsulin to insulin in fasting state and HOMA beta,the ratio of Glucose change to insulin change between at 30min and 0min time point of OGTT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015 (estimated)
- Study completionSep 2015 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaolong zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The third people's Hospital Affiliated to Shanghai Jiao Tong University, Second Affiliated Hospital of Soochow University, The First Hospital of Guiyang Medical college, Fuling Central Hospital of Chongqing City, Taizhou Hospital, Shanghai Pudong New Area Gongli Hospital
- Responsible party
- Sponsor-investigator, xiaolong zhao, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129985
- Sponsor's protocol ID
- HS2014-005
- Acronym
- T2DMRS
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Intensive Insulin Sequential Exenatide Therapy on Beta Cell Function and Glycaemic Control in Patients With Newly Diagnosed Type 2 Diabetes :a Multicenter Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT02129985
- Acronym / sponsor ID
- T2DMRS / HS2014-005
- Conditions
- Type 2 Diabetes
- Keywords
- the newly onset type 2 diabetes, short-term insulin treatment, exenatide sequential therapy, beta cell function, glycaemic remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- xiaolong zhaoUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, The third people's Hospital Affiliated to Shanghai Jiao Tong University, Second Affiliated Hospital of Soochow University, The First Hospital of Guiyang Medical college, Fuling Central Hospital of Chongqing City, Taizhou Hospital, Shanghai Pudong New Area Gongli Hospital
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 2 May 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.
Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.
Detailed description
The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus,irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.Short-term intensive insulin therapy of newly diagnosed type 2 diabetes has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is an GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatidepatients were all received a short-term intensive insulin therapy,then randomised to Exenatide group(10 ug two times a day for three months) |
| Metformin | Active comparator | Drug: Metforminpatients were all received a short-term intensive insulin therapy,then randomised to metformin group(850mg two times a day for three months) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- newly diagnosed type 2 diabetes without drug treatment
- 25-70 years old age
- Fasting glucose between 7.0-16.7mmol / L
- BMI at 20 ~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
- females who have no plan of pregnancy during the study
Key exclusion criteria (10 listed)
- acute or chronic complications of diabetes
- myocardial infarction or cerebrovascular events within three months
- serious gastrointestinal diseases
- other serious concomitant diseases
- liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
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 |
|---|---|---|
| ExenatideAlso: GLP-1 receptor agonistExenatide (10 ug/bid for 3 months) | Drug | Exenatide |
| MetforminAlso: GlucophageMetformin 850 mg/bid for 3 months | Drug | Metformin |
Primary outcome
time to glycaemic remission
Time frame: up to 1 year
time of glycaemic remission at 1 year after exenatide sequential therapy followed by a short-term insulin intensive treatment
remission rate of type 2 diabetes at a year.
Time frame: up to 1 year
remission rate of type 2 diabetes after short-term intensive insulin and exenatide sequencial therapy
1 secondary outcome
the beta cell function change
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
Related trials for Type 2 Diabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
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 Exenatide and Metformin in people with Type 2 Diabetes, run by xiaolong zhao 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 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: status not confirmed, as of the sponsor's last update on 2 May 2014. 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 xiaolong zhao, MD. (86-18918067241, xiaolongzhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to glycaemic remission (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 2 May 2014.