The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Optimal hypoglycemic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
- Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
- Patients had relatively constant diet and exercise in 2 month before the study.
- Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L
Exclusion Criteria:
- Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
- Patients with severe infectious diseases;
- Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
- Patients with history of psychiatric disorders and were unsuitable to use CGMS;
- Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optimal hypoglycemic treatment
Arm Description
The patients will receive optimal hypoglycemic treatments, including adjustment of insulin dose and oral antidiabetic agents
Outcomes
Primary Outcome Measures
Rate of reaching target of glucose
Rate of reaching target of glucose
Secondary Outcome Measures
HbA1c
Glycated hemoglobin at baseline and 3 months after reaching target of blood glucose
Dosage of insulin
Change of insulin dose
Time of reaching target of glucose
Time of reaching target of glucose
Full Information
NCT ID
NCT03659383
First Posted
June 12, 2018
Last Updated
September 5, 2018
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03659383
Brief Title
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
Official Title
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Anticipated)
Primary Completion Date
February 20, 2019 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. However, many patients who treated with glargine still have poor blood glucose control because of insufficient insulin dose or improper oral medication. This study aims to investigate the optimal treatment scheme in order to improve the blood control in these patients. Continuous Glucose Monitoring System (CGMS) will be used to assess the blood glucose control at baseline and the moment when the patients achieved standard. Oral medications will be standardized first, and insulin doses will be adjusted according to blood glucose values obtained by self-monitoring. Glycemic control will be considered as reaching target of glucose if the fasting capillary blood glucose is less than 6.1 mmol/L. The maximum period of blood glucose adjustment will be 1 months. Oral medication, the type and dosage of insulin, exercise status, insulin injection skill evaluation, islet function, duration of diabetes, complications and insulin antibodies will be recorded in detail at baseline, reaching target of glucose standard and 3 months after reaching target of glucose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optimal hypoglycemic treatment
Arm Type
Experimental
Arm Description
The patients will receive optimal hypoglycemic treatments, including adjustment of insulin dose and oral antidiabetic agents
Intervention Type
Combination Product
Intervention Name(s)
Optimal hypoglycemic treatment
Intervention Description
Standardize oral hypoglycemic medication and adjust insulin dose according to blood glucose values obtained by self-monitoring
Primary Outcome Measure Information:
Title
Rate of reaching target of glucose
Description
Rate of reaching target of glucose
Time Frame
0-1 month
Secondary Outcome Measure Information:
Title
HbA1c
Description
Glycated hemoglobin at baseline and 3 months after reaching target of blood glucose
Time Frame
0-3 month
Title
Dosage of insulin
Description
Change of insulin dose
Time Frame
0-1 month
Title
Time of reaching target of glucose
Description
Time of reaching target of glucose
Time Frame
0-1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
Patients had relatively constant diet and exercise in 2 month before the study.
Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L
Exclusion Criteria:
Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
Patients with severe infectious diseases;
Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
Patients with history of psychiatric disorders and were unsuitable to use CGMS;
Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
12. IPD Sharing Statement
Learn more about this trial
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
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