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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin lispro; Drug: Insulin Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT02526810

20130319c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

GROUP A

Active Comparator group

Description:

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

Treatment:

Drug: insulin lispro

GROUP B

Experimental group

Description:

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.

Treatment:

Drug: Insulin Glargine