Clinical trial NCT02526810: Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
Official title: Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: glargine
continuous subcutaneous insulin injection
blood glucose control
blood glucose fluctuation
Oxidative Stress
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Department of Science and Technology
First posted: 2015-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mean amplitude of glycemic excursions( MAGE)
timeFrame: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
Secondary outcomes:
measure: glycated hemoglobin A1c
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: glycated albumin
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: fasting plasma glucose, postprandial plasma glucose (30min, 120min)
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: Fasting C-peptide
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: Fasting insulin
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: Homa-β
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: insulin secretion-sensitivity index
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: disposition index
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: standard deviation of glucose level
timeFrame: during three days' CGMS
measure: area under curve (AUC) when the glucose level was higher than 7.8mmol/L
timeFrame: during three days' CGMS
measure: area under curve (AUC) when the glucose level was lower than 3.9mmol/L
timeFrame: during three days' CGMS
measure: thiobarbituric acid reactive substance
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
timeFrame: From date of randomization until the end of study, assessed up to 15 days
Other outcomes:
measure: the incidence of hypoglycemia
timeFrame: From date of randomization until the end of study, assessed up to 15 days
measure: the incidence of severe hypoglycemia
timeFrame: From date of randomization until the end of study, assessed up to 15 days
Locations:
city: Guangzhou City
country: China
facility: Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
state: Guangdong
Study officials:
affiliation: Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
name: Zeng Longyi, professor
role: PRINCIPAL_INVESTIGATOR
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