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

Phase 4

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine; Drug: insulin lispro

• Registration Number: NCT02526810
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Status Verified: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-15
• Study First Posted: 2015-08-18
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-20
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP B	Insulin Glargine	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.
GROUP A	insulin lispro	using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.

Primary Outcome Measures

Name	Time	Method
mean amplitude of glycemic excursions( MAGE)	3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days	a Medtronic dynamic blood glucose meter was applied to the patient for 72 hours, and MAGE is calculated according to the data.

Secondary Outcome Measures

Name	Time	Method
glycated albumin	From date of randomization until the end of study, assessed up to 15 days	changes of glycated albumin before and after the intervention
Fasting insulin	From date of randomization until the end of study, assessed up to 15 days	changes of Fasting insulin before and after the intervention
Homa-β	From date of randomization until the end of study, assessed up to 15 days	changes of Homa-β before and after the intervention
insulin secretion-sensitivity index	From date of randomization until the end of study, assessed up to 15 days	changes of insulin secretion-sensitivity index before and after the intervention
disposition index	From date of randomization until the end of study, assessed up to 15 days	changes of disposition index before and after the intervention
standard deviation of glucose level	during three days' CGMS	standard deviation of glucose level
fasting plasma glucose, postprandial plasma glucose (30min, 120min)	From date of randomization until the end of study, assessed up to 15 days	changes of fasting and postprandial plasma glucose before and after the intervention
Fasting C-peptide	From date of randomization until the end of study, assessed up to 15 days	changes of Fasting C-peptide before and after the intervention
glycated hemoglobin A1c	From date of randomization until the end of study, assessed up to 15 days	changes of HbA1c before and after the intervention
area under curve (AUC) when the glucose level was higher than 7.8mmol/L	during three days' CGMS	AUC when the glucose level was higher than 7.8mmol/L
area under curve (AUC) when the glucose level was lower than 3.9mmol/L	during three days' CGMS	AUC when the glucose level was higher than 3.9mmol/L
thiobarbituric acid reactive substance	From date of randomization until the end of study, assessed up to 15 days	changes of thiobarbituric acid reactive substance before and after the intervention
the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)	From date of randomization until the end of study, assessed up to 15 days	changes of the level of blood 8-OHdG substance before and after the intervention

Trial Locations

Locations (1)

Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University; 🇨🇳 Guangzhou City, Guangdong, China