CClinicalTrials.gg
Status unknownNCT03180281TONDUpdated Jun 8, 2017

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

An interventional study of DPP4 and Insulin in Type 2 Diabetes Mellitus, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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;
02

Conditions studied

  • Type 2 Diabetes Mellitus
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 135 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
135 participants (estimated)

Study arms

  • Experimental
    DPP4 group

    DPP4 inhibitor,1 pill qd

    Drug: DPP4

  • Experimental
    insulin group

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

    Drug: Insulin

  • Placebo comparator
    SU group

    SU,Glimepiride,1-2mg qd

    Drug: SU

Interventions

  • DrugDPP4

    sitagliptin phosphate 100mg qd

    Also known as: sitagliptin phosphate

  • DrugInsulin

    Insulin Glargine or detemir 0.2U/kg qd

    Also known as: Glargine or detemir

  • DrugSU

    Glimepiride 1-2mg qd

    Also known as: Glimepiride

06

What researchers measure

Primary outcomes

  1. Fasting blood glucose,glycosylated hemoglobin(GHbA1c)

    mmol/L,%

    Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months

Secondary outcomes

  1. weight loss

    kilograms

    Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months

  2. Lipid changes

    mmol/L

    Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months

  3. Incidence of hypoglycemia

    times

    Time frame: From date of randomization until the date of first documented progression, assessed up to 3 months

07

Study locations

1 site
  • First Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, Shaanxi 710061, China
    • Jing Sui, Doctor · Contact · 0086-18991989230
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03180281
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jun 8, 2017
Start date
Jul 1, 2017 (estimated)
Primary completion
Jan 1, 2020 (estimated)
Completion
Jan 1, 2020 (estimated)
Last update
Jun 8, 2017

Study contacts

Jing Sui, Doctor
Contact
suijing1029@163.com
0086-18991989230
Jing Sui, Doctor
principal investigator · First Affiliated Hospital of Xi'an Jiao Tong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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