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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
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
  2. 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;
  3. Patients had relatively constant diet and exercise in 2 month before the study.
  4. Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L

Exclusion Criteria:

  1. 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;
  2. Patients with severe infectious diseases;
  3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
  4. Patients with history of psychiatric disorders and were unsuitable to use CGMS;
  5. 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

    First Posted
    June 12, 2018
    Last Updated
    September 5, 2018
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    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

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