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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-01-01

Brief Summary

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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.

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Detailed Description

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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;

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DPP4 group

DPP4 inhibitor,1 pill qd

Group Type EXPERIMENTAL

DPP4

Intervention Type DRUG

sitagliptin phosphate 100mg qd

insulin group

insulin,glargine or detemir，0.2U/Kg,qd

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Insulin Glargine or detemir 0.2U/kg qd

SU group

SU,Glimepiride，1-2mg qd

Group Type PLACEBO_COMPARATOR

SU

Intervention Type DRUG

Glimepiride 1-2mg qd

Interventions

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DPP4

sitagliptin phosphate 100mg qd

Intervention Type DRUG

Insulin

Insulin Glargine or detemir 0.2U/kg qd

Intervention Type DRUG

SU

Glimepiride 1-2mg qd

Intervention Type DRUG

Other Intervention Names

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sitagliptin phosphate Glargine or detemir Glimepiride

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No