Therapies on Newly Diagnosed Type 2 Diabetes Patients With High Glucose Toxicity Which Protect Islet β Cell (TOND)

June 6, 2017 updated by: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients were divided into 3 groups:

  1. DPP-4 inhibitor treatment group (45 cases): DPP-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose;
  2. insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin;
  3. Sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
          • Jing Sui, Doctor
          • Phone Number: 0086-18991989230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DPP4 group
DPP4 inhibitor,1 pill qd
Drug: DPP4
sitagliptin phosphate 100mg qd
Other Names:
  • sitagliptin phosphate
EXPERIMENTAL: insulin group
insulin,glargine or detemir，0.2U/Kg,qd
Drug: Insulin
Insulin Glargine or detemir 0.2U/kg qd
Other Names:
  • Glargine or detemir
PLACEBO_COMPARATOR: SU group
SU,Glimepiride，1-2mg qd
Drug: SU
Glimepiride 1-2mg qd
Other Names:
  • Glimepiride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,%
From date of randomization until the date of first documented progression, assessed up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: From date of randomization until the date of first documented progression, assessed up to 3 months
kilograms
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
mmol/L
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
times
From date of randomization until the date of first documented progression, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Jing Sui, Doctor, First Affiliated Hospital of Xi'an Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (ACTUAL)

June 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2016LSL-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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