Diabetes Mellitus, Type 2Phase 4NCT03018665
A Study of the Effect of Glucagon-like Peptide 1(GLP-1) Receptor Agonist in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
A Phase 4 study testing Exenatide, BIAsp30 and Metformin in people with Diabetes Mellitus, Type 2, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exenatide, BIAsp30 and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2017to Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed and dated informed consent form obtained from the subject before any study related procedures take place.
- Age ≥18 years to ≤65 years at Visit 1.
- The subject has a new diagnosis of type 2 diabetes without any treatment.
- HbA1c ≥8.0% to ≤14.0% at Visit 1.
- BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
Who cannot join
- The subject has a history of type 1 diabetes or a secondary form of diabetes.
- The subject has received an anti-diabetic drug before the screening visit.
- Treatment with systemic steroids 2 months prior to screening
- Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
- The subject has a history of acute or chronic pancreatitis
- Any gastrointestinal diseases or surgeries that induce chronic malabsorption
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- Cancer and medical history of cancer(except basal cell skin cancer or squamous cell skin cancer).
- The subject has a history of recurrent severe hypoglycaemia.
- Cardiovascular disease,within the last 6months prior to screening,defined as: stroke;decompensated heart failure New York Heart Association(NYHA) class III or IV;Myocardial infarction;unstable angina pectoris;or coronary bypass graft or angioplasty.
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure ≥180 millimetre(mm) mercury(Hg) and/or diastolic blood pressure ≥100 millimetre(mm) mercury(Hg).
- Impaired liver function,defined as alanine aminotransferase(ALT) or aspartate aminotransferase(AST) ≥2.5 times upper limit of normal.
- Impaired renal function,defined as serum-creatinine ≥125umol/l for males and ≥110umol/l for females.
- Females who are pregnant or breast-feeding, males and females of childbearing potential,who do not agree to prevent conception during the study.
- Known or suspected abuse of alcohol,narcotics or illicit drugs.
Trial locations and contacts
1 site in 1 country.
Guixia Wang, PhD contact
China1 site
First Hospital of Jilin University
Changchun, Jilin, 130021
Guixia Wang, PhD, gwang168@jlu.edu.cn
About this study
Official title: A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
The purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
Read the detailed description
Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exenatide, BIAsp30, Metformin
- 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
subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month
BIAsp30Drug
subcutaneous injection，fit dosage twice a day in three months
MetforminDrug
oral，0.85g，twice a day in three months
| Study group | Role | What they receive |
|---|---|---|
| Exenatide and Metformin | Experimental | Exenatide in Combination With Metformin Receives: Drug: Exenatide; Drug: Metformin |
| BIAsp30 and Metformin | Active comparator | BIAsp30 in Combination With Metformin Receives: Drug: BIAsp30; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Inducing Diabetes Remission
Measured: At the end of 12-week treatment
Change of Rate of Maintaining Diabetes Remission
Measured: 3,6,12,24,36 months after 12-week treatment
Time of Maintaining Diabetes Remission
Measured: up to 36 months after 12-week treatment
Secondary outcomes (10)
Change of Blood Pressure
Measured: Baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Heart Rate
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Weight
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Waistline
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Glycosylated Hemoglobin
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Pancreatic Beta-cell Function
Pancreatic Beta-cell Function will be evaluated by insulin releasing test. The fasting and 2-hour postprandial plasma glucose concentrations and serum insulin concentrations will be tested.
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Insulin Resistance Index
Measured: baseline and 0,3,6,12,24,36 months after 12-week treatment
The Incidence of Hypoglycemia
Measured: During the 12-week treatment
The Incidence of Diabetic Retinopathy
Measured: up to 36 months after 12-week treatment
The Incidence of Diabetic Nephropathy
Measured: up to 36 months after 12-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guixia Wang, The First Hospital of Jilin University
- Investigators
- Guixia Wang, PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018665
- Sponsor's protocol ID
- JLUEND001
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Active-controlled,Open-label Clinical Trial to Evaluate the Effect of GLP-1 Receptor Agonist (Exenatide Injection) in Combination With Metformin Therapy Compared to Premixed Insulin (BIAsp30) in Combination With Metformin Therapy on Diabetes Remission in Subjects With Newly Diagnosed Type 2 Diabetes Who Are Overweight or Obese
- ClinicalTrials.gov ID
- NCT03018665
- Acronym / sponsor ID
- JLUEND001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Dec 2021 (estimated)
- First posted
- 12 Jan 2017 (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 purpose of this study is to determine the effect of GLP-1 receptor agonist on inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese
Detailed description
Most of type 2 diabetes are characterized by being overweight or obese mainly caused by insulin resistance. GLP-1 receptor agonist has been proved to help to lose weight and improve insulin resistance. In this study, we suppose that GLP-1 receptor agonist has the effect of inducing diabetes remission in newly diagnosed type 2 diabetes who are overweight or obese and has its advantages
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide and Metformin | Experimental | Drug: Exenatide, Drug: MetforminExenatide in Combination With Metformin |
| BIAsp30 and Metformin | Active comparator | Drug: BIAsp30, Drug: MetforminBIAsp30 in Combination With Metformin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A signed and dated informed consent form obtained from the subject before any study related procedures take place.
- Age ≥18 years to ≤65 years at Visit 1.
- The subject has a new diagnosis of type 2 diabetes without any treatment.
- HbA1c ≥8.0% to ≤14.0% at Visit 1.
- BMI(Body Mass Index)≥24kg/m2 to ≤40kg/m2 at Visit 1.
Key exclusion criteria (14 listed)
- The subject has a history of type 1 diabetes or a secondary form of diabetes.
- The subject has received an anti-diabetic drug before the screening visit.
- Treatment with systemic steroids 2 months prior to screening
- Treatment with anti-obesity drug 2 months prior to screening or any other treatment at the time of screening(i.e. surgery etc) leading to unstable body weight.
- The subject has a history of acute or chronic pancreatitis
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 |
|---|---|---|
| Exenatidesubcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month | Drug | Exenatide and Metformin |
| BIAsp30subcutaneous injection，fit dosage twice a day in three months | Drug | BIAsp30 and Metformin |
| Metforminoral，0.85g，twice a day in three months | Drug | BIAsp30 and Metformin, Exenatide and Metformin |
Primary outcome
Rate of Inducing Diabetes Remission
Time frame: At the end of 12-week treatment
Change of Rate of Maintaining Diabetes Remission
Time frame: 3,6,12,24,36 months after 12-week treatment
Time of Maintaining Diabetes Remission
Time frame: up to 36 months after 12-week treatment
10 secondary outcomes
Change of Blood Pressure
Time frame: Baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Heart Rate
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Weight
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Waistline
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Glycosylated Hemoglobin
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Pancreatic Beta-cell Function
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
Change of Insulin Resistance Index
Time frame: baseline and 0,3,6,12,24,36 months after 12-week treatment
The Incidence of Hypoglycemia
Time frame: During the 12-week treatment
The Incidence of Diabetic Retinopathy
Time frame: up to 36 months after 12-week treatment
The Incidence of Diabetic Nephropathy
Time frame: up to 36 months after 12-week treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Guixia Wang, PhD contact
Guixia Wang, PhD principal investigator
The First Hospital of Jilin 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 Exenatide, BIAsp30 and Metformin in people with Diabetes Mellitus, Type 2, run by The First Hospital of Jilin University 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 14 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 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guixia Wang, PhD (gwang168@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Inducing Diabetes Remission (time frame: At the end of 12-week treatment). The study lists 3 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 12 Jan 2017.