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Status unknownNCT03659383Updated Sep 6, 2018

The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine

A Phase 4 interventional study of Optimal hypoglycemic treatment in Type2 Diabetes, sponsored by Nanjing First Hospital, Nanjing Medical University. Status unknown. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
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Study 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.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Optimal hypoglycemic treatment

    The patients will receive optimal hypoglycemic treatments, including adjustment of insulin dose and oral antidiabetic agents

    Combination Product: Optimal hypoglycemic treatment

Interventions

  • Combination productOptimal hypoglycemic treatment

    Standardize oral hypoglycemic medication and adjust insulin dose according to blood glucose values obtained by self-monitoring

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What researchers measure

Primary outcomes

  1. Rate of reaching target of glucose

    Rate of reaching target of glucose

    Time frame: 0-1 month

Secondary outcomes

  1. HbA1c

    Glycated hemoglobin at baseline and 3 months after reaching target of blood glucose

    Time frame: 0-3 month

  2. Dosage of insulin

    Change of insulin dose

    Time frame: 0-1 month

  3. Time of reaching target of glucose

    Time of reaching target of glucose

    Time frame: 0-1 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03659383
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Sep 6, 2018
Start date
Sep 20, 2018 (estimated)
Primary completion
Feb 20, 2019 (estimated)
Completion
Mar 31, 2019 (estimated)
Last update
Sep 6, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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