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

NCT03180281 | Unknown

• 1 other identifier: XJTU1AF2016LSL-048
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Fasting blood glucose,glycosylated hemoglobin(GHbA1c)

  mmol/L,%

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

Secondary Outcomes (3)

• weight loss

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

• Lipid changes

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

• Incidence of hypoglycemia

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

Study Arms (3)

DPP4 group

EXPERIMENTAL

DPP4 inhibitor,1 pill qd

Drug: DPP4

insulin group

EXPERIMENTAL

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

Drug: Insulin

SU group

PLACEBO COMPARATOR

SU,Glimepiride，1-2mg qd

Drug: SU

Interventions

DPP4 DRUG

sitagliptin phosphate 100mg qd

Also known as: sitagliptin phosphate

DPP4 group

Insulin DRUG

Insulin Glargine or detemir 0.2U/kg qd

Also known as: Glargine or detemir

insulin group

SU DRUG

Glimepiride 1-2mg qd

Also known as: Glimepiride

SU group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly onset
• type 2 diabetes
• BMI 18-30kg/m2
• FBS≧11.1mmol/L，GHbA1c≧9%
• urine ket ≦(1+)
• Normal liver and kidney function

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• 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.

  PMID: 33574913 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Insulin; Insulin Glargine; Insulin Detemir; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Jing Sui, Doctor

  First Affiliated Hospital of Xi'an Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Sui, Doctor

CONTACT

0086-18991989230; suijing1029@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: June 8, 2017
• Study Start: July 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 8, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)