Diabetes Mellitus, Type 2Phase 4COGFOSTNCT02526810
Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
A Phase 4 study testing insulin lispro and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- insulin lispro and Insulin Glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
- 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
- Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
- agree to participate the study and sign the informed consent.
Who cannot join
- obvious failure of heart, hepatic, kidney function.
- severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
- women in pregnancy or planning to get pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
Guangzhou, Guangdong, 510630
Zeng Longyi, Professor, 0086-020-85252160, zssynfmk@163.com
Lin Shuo, Doctor, 0086-020-85253408, littltpig@yeah.net
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- insulin lispro, Insulin Glargine
- Keywords
- glargine, continuous subcutaneous insulin injection, blood glucose control, blood glucose fluctuation, Oxidative Stress
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin lisproDrug
Also called Humalog
continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
Insulin GlargineDrug
Also called Lantus
long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Active comparator | using continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg. Receives: Drug: insulin lispro |
| GROUP B | Experimental | 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. Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-5 days after patients achieving the target glucose levels, From date of randomization, assessed up to 10 days
Secondary outcomes (13)
glycated hemoglobin A1c
changes of HbA1c before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
glycated albumin
changes of glycated albumin before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
fasting plasma glucose, postprandial plasma glucose (30min, 120min)
changes of fasting and postprandial plasma glucose before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
Fasting C-peptide
changes of Fasting C-peptide before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
Fasting insulin
changes of Fasting insulin before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
Homa-β
changes of Homa-β before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
insulin secretion-sensitivity index
changes of insulin secretion-sensitivity index before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
disposition index
changes of disposition index before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
standard deviation of glucose level
standard deviation of glucose level
Measured: during three days' CGMS
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
Measured: during three days' CGMS
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
Measured: during three days' CGMS
thiobarbituric acid reactive substance
changes of thiobarbituric acid reactive substance before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
the level of blood 8-hydroxy-2-deoxyguanosine(8-OHdG)
changes of the level of blood 8-OHdG substance before and after the intervention
Measured: From date of randomization until the end of study, assessed up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Responsible party
- Principal investigator, Longyi Zeng, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zeng Longyi, professor, Principal investigator, Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526810
- Sponsor's protocol ID
- 20130319c
- Acronym
- COGFOST
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20335585Weng 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.
PubMed 18502299Mu 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 beta-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.
PubMed 21898754Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-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.
PubMed 21877913Brun 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. doi: 10.2337/diacare.24.9.1685. No abstract available.
PubMed 11522721Muggeo 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. doi: 10.2337/diacare.23.1.45.
PubMed 10857967Reznik 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.
PubMed 24998009Hanson 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. doi: 10.1093/oxfordjournals.aje.a010187.
PubMed 10645822
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02526810
- Acronym / sponsor ID
- COGFOST / 20130319c
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- glargine, continuous subcutaneous insulin injection, blood glucose control, blood glucose fluctuation, Oxidative Stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Active comparator | Drug: insulin lisprousing continuous subcutaneous insulin injection with insulin lispro, Humalog, initiating with 0.5-0.8 IU/kg. |
| GROUP B | Experimental | Drug: Insulin Glargineusing 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
- 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
- Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
- agree to participate the study and sign the informed consent.
Key exclusion criteria (3 listed)
- obvious failure of heart, hepatic, kidney function.
- severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
- women in pregnancy or planning to get pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin lisproAlso: Humalogcontinuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level | Drug | GROUP A |
| Insulin GlargineAlso: Lantuslong-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level | Drug | GROUP B |
Primary outcome
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.
13 secondary outcomes
glycated hemoglobin A1c
Time frame: 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
fasting plasma glucose, postprandial plasma glucose (30min, 120min)
Time frame: 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
Fasting insulin
Time frame: 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
insulin secretion-sensitivity index
Time frame: 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
standard deviation of glucose level
Time frame: during three days' CGMS
area under curve (AUC) when the glucose level was higher than 7.8mmol/L
Time frame: during three days' CGMS
area under curve (AUC) when the glucose level was lower than 3.9mmol/L
Time frame: during three days' CGMS
thiobarbituric acid reactive substance
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Background: PubMed 20335585Yang 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.
- Background: PubMed 18502299Weng 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.
- Background: PubMed 21898754Mu 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 beta-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.
- Background: PubMed 21877913Zeng L, Lu H, Deng H, Mu P, Li X, Wang M. Noninferiority effects on glycemic control and beta-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.
- Background: PubMed 11522721Brun 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. doi: 10.2337/diacare.24.9.1685. No abstract available.
- Background: PubMed 10857967Muggeo 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. doi: 10.2337/diacare.23.1.45.
- Background: PubMed 24998009Reznik 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.
- Background: PubMed 10645822Hanson 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. doi: 10.1093/oxfordjournals.aje.a010187.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeng Longyi, professor principal investigator
Endocrinology department of the Third Affiliated Hospital of Sun Yet-san University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin lispro and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeng Longyi, professor (0086-020-85252160, zssynfmk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526810, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.