Type 2 Diabetes MellitusTONDNCT03180281
Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell
A study testing DPP4, Insulin and SU in people with Type 2 Diabetes Mellitus, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- DPP4, Insulin and SU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jan 2020
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly onset
- type 2 diabetes
- BMI 18-30kg/m2
- FBS≧11.1mmol/L，GHbA1c≧9%
- urine ket ≦(1+)
- Normal liver and kidney function
Who cannot join
- type 1 diabetes
- renal or hepatic insufficiency
- Severe ketoacidosis
- Treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs
- Severe systemic disease
- History of pancreatitis or pancreatic surgery
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
Jing Sui, Doctor, 0086-18991989230
About this study
Official title: Exploring Effective and Safety Therapies Which Protect Islet β Cell on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity
Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.It is urgent to explore more effective and safety treatments which can also protect islet cells function.How to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.
Read the detailed description
Patients were divided into 3 groups:
- DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;
- insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;
- Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DPP4, Insulin, SU
- 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.
DPP4Drug
Also called sitagliptin phosphate
sitagliptin phosphate 100mg qd
InsulinDrug
Also called Glargine or detemir
Insulin Glargine or detemir 0.2U/kg qd
SUDrug
Also called Glimepiride
Glimepiride 1-2mg qd
| Study group | Role | What they receive |
|---|---|---|
| DPP4 group | Experimental | DPP4 inhibitor,1 pill qd Receives: Drug: DPP4 |
| insulin group | Experimental | insulin,glargine or detemir，0.2U/Kg,qd Receives: Drug: Insulin |
| SU group | Placebo comparator | SU,Glimepiride，1-2mg qd Receives: Drug: SU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
mmol/L,%
Measured: From date of randomization until the date of first documented progression, assessed up to 3 months
Secondary outcomes (3)
weight loss
kilograms
Measured: From date of randomization until the date of first documented progression, assessed up to 3 months
Lipid changes
mmol/L
Measured: From date of randomization until the date of first documented progression, assessed up to 3 months
Incidence of hypoglycemia
times
Measured: From date of randomization until the date of first documented progression, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Sui, Doctor, Principal investigator, First Affiliated Hospital of Xi'an Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180281
- Sponsor's protocol ID
- XJTU1AF2016LSL-048
- Acronym
- TOND
- Status last verified
- Jan 2017
- First submitted
- 20 Mar 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He M, Deng M, Wang J, Fan P, Wang Y, Zhao X, He Y, Shi B, Sui J. Efficacy and tolerability of sitagliptin and metformin compared with insulin as an initial therapy for newly diagnosed diabetic patients with severe hyperglycaemia. Exp Ther Med. 2021 Mar;21(3):217. doi: 10.3892/etm.2021.9649. Epub 2021 Jan 15.
PubMed 33574913
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Effective and Safety Therapies Which Protect Islet β Cell on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity
- ClinicalTrials.gov ID
- NCT03180281
- Acronym / sponsor ID
- TOND / XJTU1AF2016LSL-048
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 8 Jun 2017 (actual)
- 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.
Prevalence of diabetes is increasing rapidly both in China and all over the world.Hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."High glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.It is an important cause of β cell dysfunction.High glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.It is urgent to explore more effective and safety treatments which can also protect islet cells function.How to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.Our aim is to explore the non-inferiority of new antidiabetic drugs DPP4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.
Detailed description
Patients were divided into 3 groups:
- DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;
- insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;
- Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPP4 group | Experimental | Drug: DPP4DPP4 inhibitor,1 pill qd |
| insulin group | Experimental | Drug: Insulininsulin,glargine or detemir，0.2U/Kg,qd |
| SU group | Placebo comparator | Drug: SUSU,Glimepiride，1-2mg qd |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- newly onset
- type 2 diabetes
- BMI 18-30kg/m2
- FBS≧11.1mmol/L，GHbA1c≧9%
- urine ket ≦(1+)
Key exclusion criteria (7 listed)
- type 1 diabetes
- renal or hepatic insufficiency
- Severe ketoacidosis
- Treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs
- Severe systemic disease
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 |
|---|---|---|
| DPP4Also: sitagliptin phosphatesitagliptin phosphate 100mg qd | Drug | DPP4 group |
| InsulinAlso: Glargine or detemirInsulin Glargine or detemir 0.2U/kg qd | Drug | insulin group |
| SUAlso: GlimepirideGlimepiride 1-2mg qd | Drug | SU group |
Primary outcome
Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months
mmol/L,%
3 secondary outcomes
weight loss
Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months
Lipid changes
Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months
Incidence of hypoglycemia
Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 33574913He M, Deng M, Wang J, Fan P, Wang Y, Zhao X, He Y, Shi B, Sui J. Efficacy and tolerability of sitagliptin and metformin compared with insulin as an initial therapy for newly diagnosed diabetic patients with severe hyperglycaemia. Exp Ther Med. 2021 Mar;21(3):217. doi: 10.3892/etm.2021.9649. Epub 2021 Jan 15.
- Individual participant dataSharing planned: No
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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.
Jing Sui, Doctor principal investigator
First Affiliated Hospital of Xi'an Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPP4, Insulin and SU in people with Type 2 Diabetes Mellitus, run by First Affiliated Hospital Xi'an Jiaotong 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 6 inclusion and 7 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 8 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jing Sui, Doctor (0086-18991989230, suijing1029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose,glycosylated hemoglobin(GHbA1c) (time frame: From date of randomization until the date of first documented progression, assessed up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180281, which also lists 1 linked publication.
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 8 Jun 2017.