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

Diabetes Mellitus, Type 2 Clinical Trial

— COGFOST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02526810
• Other study ID #: 20130319c
• Status: Recruiting
• Phase: Phase 4
• First received: August 10, 2015
• Last updated: August 19, 2015
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Zeng Longyi, professor
• Phone: 0086-020-85252160
• Email: zssynfmk[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Description:

This study was a single-center, randomized, controled and prospective trial. Type 2 diabetic patients were randomized into 2 groups (Group A and Group B). Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al. The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

1. investigator diagnosed type 2 diabetes( 1999 WHO diagnosis 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:

1. obvious failure of heart, hepatic, kidney function.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University	Guangzhou City	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	Guangdong Provincial Department of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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 ß-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and ß-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. Erratum in: Diabetes Technol Ther. 2014 Mar;16(3):193. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the incidence of hypoglycemia	the incidence of hypoglycemia, defined as blood glucose lower than 3.9mmol/L	From date of randomization until the end of study, assessed up to 15 days	Yes
Other	the incidence of severe hypoglycemia	defined as hypoglycemia which need other people's help or blood glucose lower than 2.8mmol/L	From date of randomization until the end of study, assessed up to 15 days	Yes
Primary	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	No
Secondary	glycated hemoglobin A1c	changes of HbA1c before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	glycated albumin	changes of glycated albumin before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	fasting plasma glucose, postprandial plasma glucose (30min, 120min)	changes of fasting and postprandial plasma glucose before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	Fasting C-peptide	changes of Fasting C-peptide before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	Fasting insulin	changes of Fasting insulin before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	Homa-ß	changes of Homa-ß before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	insulin secretion-sensitivity index	changes of insulin secretion-sensitivity index before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	disposition index	changes of disposition index before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	standard deviation of glucose level	standard deviation of glucose level	during three days' CGMS	No
Secondary	area under curve (AUC) when the glucose level was higher than 7.8mmol/L	AUC when the glucose level was higher than 7.8mmol/L	during three days' CGMS	No
Secondary	area under curve (AUC) when the glucose level was lower than 3.9mmol/L	AUC when the glucose level was higher than 3.9mmol/L	during three days' CGMS	Yes
Secondary	thiobarbituric acid reactive substance	changes of thiobarbituric acid reactive substance before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No
Secondary	the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)	changes of the level of blood 8-OHdG substance before and after the intervention	From date of randomization until the end of study, assessed up to 15 days	No