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

NCT03659383 | Unknown Phase 4

• 1 other identifier: KY20170904-03
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of reaching target of glucose

  Rate of reaching target of glucose

  0-1 month

Secondary Outcomes (3)

• HbA1c

  0-3 month

• Dosage of insulin

  0-1 month

• Time of reaching target of glucose

  0-1 month

Study Arms (1)

Optimal hypoglycemic treatment

EXPERIMENTAL

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

Combination Product: Optimal hypoglycemic treatment

Interventions

Optimal hypoglycemic treatment COMBINATION_PRODUCT

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

Optimal hypoglycemic treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: September 6, 2018
• Study Start: September 20, 2018
• Primary Completion: February 20, 2019
• Study Completion: March 31, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-06