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

August 19, 2015 updated by: Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zeng Longyi, Professor
  • Phone Number: 0086-020-85252160
  • Email: zssynfmk@163.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou City, Guangdong, China, 510630
        • Recruiting
        • Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
        • Contact:
          • Zeng Longyi, Professor
          • Phone Number: 0086-020-85252160
          • Email: zssynfmk@163.com
        • Contact:
        • Principal Investigator:
          • Zeng Longyi, Professor
        • Sub-Investigator:
          • lin Shuo, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GROUP A
using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg.
Drug: insulin lispro
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Other Names:
  • Humalog
Experimental: GROUP B
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
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean amplitude of glycemic excursions( MAGE)
Time Frame: 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.
3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of hypoglycemia
Time Frame: From date of randomization until the end of study, assessed up to 15 days
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
the incidence of severe hypoglycemia
Time Frame: From date of randomization until the end of study, assessed up to 15 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Guangdong Provincial Department of Science and Technology

Investigators

  • Principal Investigator: Zeng Longyi, professor, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 15, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20130319c

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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