Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
NCT ID: NCT02526810
Last Updated: 2015-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2015-07-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects
NCT06688123
Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM
NCT02887625
The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
NCT01342042
Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control
NCT07244003
A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
NCT07018453
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
GROUP B
using glargine combined with oral drugs: insulin glargine, Lantus( initiating with 0.2 IU/kg) with metformin hydrochloride, Glucophage 500mg bid and gliclazide modified release tablets, Diamicron modified release(MR) tablets 60mg qd.
Insulin Glargine
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Insulin Glargine
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
3. Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
4. agree to participate the study and sign the informed consent.
Exclusion Criteria
2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
3. women in pregnancy or planning to get pregnancy.
25 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Provincial Department of Science and Technology
UNKNOWN
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Longyi Zeng
Head of Endocrinology and Metabolism department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zeng Longyi, professor
Role: PRINCIPAL_INVESTIGATOR
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Yang W, Lu J, Weng J, Jia W, Ji L, Xiao J, Shan Z, Liu J, Tian H, Ji Q, Zhu D, Ge J, Lin L, Chen L, Guo X, Zhao Z, Li Q, Zhou Z, Shan G, He J; China National Diabetes and Metabolic Disorders Study Group. Prevalence of diabetes among men and women in China. N Engl J Med. 2010 Mar 25;362(12):1090-101. doi: 10.1056/NEJMoa0908292.
Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
Mu PW, Chen YM, Lu HY, Wen XQ, Zhang YH, Xie RY, Shu J, Wang MM, Zeng LY. Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes. Diabetes Metab Res Rev. 2012 Mar;28(3):236-40. doi: 10.1002/dmrr.1292.
Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-cell function improvement in newly diagnosed type 2 diabetes patients: basal insulin monotherapy versus continuous subcutaneous insulin infusion treatment. Diabetes Technol Ther. 2012 Jan;14(1):35-42. doi: 10.1089/dia.2011.0123. Epub 2011 Aug 30.
Brun E, Zoppini G, Zamboni C, Bonora E, Muggeo M. Glucose instability is associated with a high level of circulating p-selectin. Diabetes Care. 2001 Sep;24(9):1685. doi: 10.2337/diacare.24.9.1685. No abstract available.
Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. doi: 10.2337/diacare.23.1.45.
Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.
Hanson RL, Pratley RE, Bogardus C, Narayan KM, Roumain JM, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC. Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemiologic studies. Am J Epidemiol. 2000 Jan 15;151(2):190-8. doi: 10.1093/oxfordjournals.aje.a010187.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20130319c
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.