Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus

NCT04847219 | Completed

• 1 other identifier: KY20190926-01
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• TIme in range

  change of TIme in range

  baseline and after 3 month

Secondary Outcomes (6)

• HbA1c

  after 3 month

• antibody of insulin

  baseline and after 3 month

• angrogen levels

  baseline and after 3 month

• exercise time daily

  baseline and after 3 month

• meal times

  baseline and after 3 month

Study Arms (2)

Professional flash glucose mornitoring

PLACEBO COMPARATOR

Professional flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via capillary blood glucose tests, but nor FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.

Device: Professional flash glucose mornitoring

Personal flash glucose mornitoring

ACTIVE COMPARATOR

Personal flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.

Device: Personal flash glucose mornitoring

Interventions

Professional flash glucose mornitoring DEVICE

Subjects will use Professional flash glucose mornitoring once a month for 3 months.

Professional flash glucose mornitoring

Personal flash glucose mornitoring DEVICE

Subjects will use Personal flash glucose mornitoring once a month for 3 months.

Personal flash glucose mornitoring

Eligibility Criteria

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

You may qualify if:

• participate voluntarily and sign the subject informed consent before the test.
• for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months.
• no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
• subjects are able and willing to undergo FGM examination, diet and exercise regularly.

You may not qualify if:

• patients treated with GLP-1 agonist in the last 3 months
• patients who are allergic to insulin.
• impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
• a history of drug abuse and alcohol dependence within the past 5 years.
• used systemic hormone therapy in recent 3 months.
• patients with poor compliance and irregular diet and exercise.
• patients with infection and stress within four weeks.
• patients who cannot tolerate flash glucose mornitoring.
• patients who are pregnant, nursing or or preparing to become pregnant.
• any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• Wuxi Hospital of Traditional Chinese Medicine: collaborator
• Wuxi People's Hospital Affiliated to Nanjing Medical University: collaborator
• Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University: collaborator
• The Affiliated Suqian First People's Hospital of Nanjing Medical University: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location

Related Publications (3)

• Kong D, Shen Z, Jiang L, Xie X, Yan R, Jing T, Hu Y, Ma J. The effects of vildagliptin on glycemic variability in patients with type 2 diabetes on premixed insulin therapy. Front Endocrinol (Lausanne). 2025 Jun 20;16:1508918. doi: 10.3389/fendo.2025.1508918. eCollection 2025.

  PMID: 40620795 DERIVED

• Yan RN, Cai TT, Jiang LL, Jing T, Cai L, Xie XJ, Su XF, Xu L, He K, Cheng L, Cheng C, Liu BL, Hu Y, Ma JH. Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy. Front Endocrinol (Lausanne). 2022 Feb 10;13:832102. doi: 10.3389/fendo.2022.832102. eCollection 2022.

  PMID: 35222287 DERIVED

• Cai T, Hu Y, Ding B, Yan R, Liu B, Cai L, Jing T, Jiang L, Xie X, Wang Y, Wang H, Zhou Y, He K, Xu L, Chen L, Cheng C, Ma J. Effect of Metformin on Testosterone Levels in Male Patients With Type 2 Diabetes Mellitus Treated With Insulin. Front Endocrinol (Lausanne). 2021 Dec 24;12:813067. doi: 10.3389/fendo.2021.813067. eCollection 2021.

  PMID: 35002984 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jianhua Ma, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: April 19, 2021
• Study Start: October 9, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-04

Locations

CN (1)