Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell (TOND)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DPP4
Insulin
SU
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- newly onset
- type 2 diabetes
- BMI 18-30kg/m2
- FBS≧11.1mmol/L,GHbA1c≧9%
- urine ket ≦(1+)
- Normal liver and kidney function
Exclusion Criteria:
- 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
Sites / Locations
- First Affiliated Hospital of Xi'an Jiao Tong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
DPP4 group
insulin group
SU group
Arm Description
DPP4 inhibitor,1 pill qd
insulin,glargine or detemir,0.2U/Kg,qd
SU,Glimepiride,1-2mg qd
Outcomes
Primary Outcome Measures
Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
mmol/L,%
Secondary Outcome Measures
weight loss
kilograms
Lipid changes
mmol/L
Incidence of hypoglycemia
times
Full Information
NCT ID
NCT03180281
First Posted
March 20, 2017
Last Updated
June 6, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT03180281
Brief Title
Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell
Acronym
TOND
Official Title
Exploring Effective and Safety Therapies Which Protect Islet β Cell on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DPP4 group
Arm Type
Experimental
Arm Description
DPP4 inhibitor,1 pill qd
Arm Title
insulin group
Arm Type
Experimental
Arm Description
insulin,glargine or detemir,0.2U/Kg,qd
Arm Title
SU group
Arm Type
Placebo Comparator
Arm Description
SU,Glimepiride,1-2mg qd
Intervention Type
Drug
Intervention Name(s)
DPP4
Other Intervention Name(s)
sitagliptin phosphate
Intervention Description
sitagliptin phosphate 100mg qd
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Glargine or detemir
Intervention Description
Insulin Glargine or detemir 0.2U/kg qd
Intervention Type
Drug
Intervention Name(s)
SU
Other Intervention Name(s)
Glimepiride
Intervention Description
Glimepiride 1-2mg qd
Primary Outcome Measure Information:
Title
Fasting blood glucose,glycosylated hemoglobin(GHbA1c)
Description
mmol/L,%
Time Frame
From date of randomization until the date of first documented progression, assessed up to 3 months
Secondary Outcome Measure Information:
Title
weight loss
Description
kilograms
Time Frame
From date of randomization until the date of first documented progression, assessed up to 3 months
Title
Lipid changes
Description
mmol/L
Time Frame
From date of randomization until the date of first documented progression, assessed up to 3 months
Title
Incidence of hypoglycemia
Description
times
Time Frame
From date of randomization until the date of first documented progression, assessed up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly onset
type 2 diabetes
BMI 18-30kg/m2
FBS≧11.1mmol/L,GHbA1c≧9%
urine ket ≦(1+)
Normal liver and kidney function
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sui, Doctor
Phone
0086-18991989230
Email
suijing1029@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Sui, Doctor
Organizational Affiliation
First Affiliated Hospital of Xi'an Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sui, Doctor
Phone
0086-18991989230
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33574913
Citation
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.
Results Reference
derived
Learn more about this trial
Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell
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