Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes

NCT02526810 | Unknown Phase 4

• 1 other identifier: 20130319c
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.

Conditions

Diabetes Mellitus, Type 2

Keywords

glargine; continuous subcutaneous insulin injection; blood glucose control; blood glucose fluctuation; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• mean amplitude of glycemic excursions( MAGE)

  a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.

  3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days

Secondary Outcomes (13)

• glycated hemoglobin A1c

  From date of randomization until the end of study, assessed up to 15 days

• glycated albumin

  From date of randomization until the end of study, assessed up to 15 days

• fasting plasma glucose, postprandial plasma glucose (30min, 120min)

  From date of randomization until the end of study, assessed up to 15 days

• Fasting C-peptide

  From date of randomization until the end of study, assessed up to 15 days

• Fasting insulin

  From date of randomization until the end of study, assessed up to 15 days

Other Outcomes (2)

• the incidence of hypoglycemia

  From date of randomization until the end of study, assessed up to 15 days

• the incidence of severe hypoglycemia

  From date of randomization until the end of study, assessed up to 15 days

Study Arms (2)

GROUP A

ACTIVE COMPARATOR

using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.

Drug: insulin lispro

GROUP B

EXPERIMENTAL

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.

Drug: Insulin Glargine

Interventions

insulin lispro DRUG

continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level

Also known as: Humalog

GROUP A

Insulin Glargine DRUG

long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level

Also known as: Lantus

GROUP B

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
• 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
• Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
• agree to participate the study and sign the informed consent.

You may not qualify if:

• obvious failure of heart, hepatic, kidney function.
• severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
• women in pregnancy or planning to get pregnancy.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• Guangdong Provincial Department of Science and Technology: collaborator

Study Sites (1)

Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 20335585 BACKGROUND

• 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.

  PMID: 18502299 BACKGROUND

• 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.

  PMID: 21898754 BACKGROUND

• 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.

  PMID: 21877913 BACKGROUND

• 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.

  PMID: 11522721 BACKGROUND

• 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.

  PMID: 10857967 BACKGROUND

• 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.

  PMID: 24998009 BACKGROUND

• 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.

  PMID: 10645822 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Zeng Longyi, professor

  Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeng Longyi, professor

CONTACT

0086-020-85252160; zssynfmk@163.com

Lin Shuo, doctor

CONTACT

0086-020-85253408; littltpig@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology and Metabolism department

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 18, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

CN (1)