Regimen Switch After Intensive Insulin Therapy

Insulin Clinical Trial

Official title:

Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833413
• Other study ID #: ZSE-202104
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Xiao ying Li, MD
• Phone: 13651913857
• Email: xiaoying_li[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Insulin intensive therapy have traditionally been considered a sequential therapy in type 2 diabetes last choice, a number of guidelines and consensus recommendations insulin intensive therapy can be as obvious hyperglycemia in patients with newly diagnosed T2DM part of a line, a subset of patients after insulin intensive treatment target often need to change to other treatments, especially for senile diabetes patients, due to its self management ability, simplify the insulin solution is more urgent. Current clinical guidelines do not provide specific clinical guidance, such as the timing and method of switch after initial insulin intensive therapy. The purpose of this study was to explore the timing, suitable population and conversion methods of insulin regimens after treatment.

Description:

Selecting initial insulin intensive therapy during the period of hospitalization in patients with type 2 diabetes, collect the basic information and biochemical information collection, including gender, age, duration of diabetes, intensive glucose-lowering treatment plan before treatment, diabetes complications, merger disease, smoking, drinking, height, weight, blood pressure, fasting glucose, glycosylated hemoglobin and glycosylated serum protein, insulin, c-peptide, liver and kidney function, blood lipid, blood routine, hypoglycemia is happening almost 1 month. Follow-up was conducted in January, March and June. Endocrinologists decide whether to continue the original hypoglycemic regimen or adjust it according to the glycemic control goals, islet β-cell function, diabetes complications, complications, hypoglycemia and other combination drugs, as well as patients' treatment willingness and compliance. To compare the timing of conversion of treatment regimens, the proportion of conversion to each regimen and the situation of reaching the standard, and to further analyze and compare the characteristics of people who switched to different regimens, in order to establish the basis for the selection of adjustment regimens after insulin treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes;

• Patients who started intensive insulin therapy during hospitalization

• Age =18 years old

Exclusion Criteria:

• Type 1 diabetes, special type diabetes

• Acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity)

• Severe infection

• pregnancy or planned pregnancy

• Participating in other clinical studies or trials

Related Conditions & MeSH terms

• Insulin

Intervention

Drug:
• Continuous intensive insulin therapy
After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge

Locations

Country	Name	City	State
China	Department of Endocrinoogy, Zhongshan Hospital Fudan University	Shanghai
China	Zhongshan hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

American Diabetes Association. 15. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S211-S220. doi: 10.2337/dc21-S015. — View Citation

Bellido V, Suarez L, Rodriguez MG, Sanchez C, Dieguez M, Riestra M, Casal F, Delgado E, Menendez E, Umpierrez GE. Comparison of Basal-Bolus and Premixed Insulin Regimens in Hospitalized Patients With Type 2 Diabetes. Diabetes Care. 2015 Dec;38(12):2211-6. — View Citation

Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7): — View Citation

Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association — View Citation

Home PD, Dain MP, Freemantle N, Kawamori R, Pfohl M, Brette S, Pilorget V, Scherbaum WA, Vespasiani G, Vincent M, Balkau B. Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 — View Citation

Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin opt — View Citation

Lind M, Hirsch IB, Tuomilehto J, Dahlqvist S, Ahren B, Torffvit O, Attvall S, Ekelund M, Filipsson K, Tengmark BO, Sjoberg S, Pehrsson NG. Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial — View Citation

Mauricio D, Meneghini L, Seufert J, Liao L, Wang H, Tong L, Cali A, Stella P, Carita P, Khunti K. Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA. Diabetes Obes Metab. 2017 Aug;19( — View Citation

Russell-Jones D, Pouwer F, Khunti K. Identification of barriers to insulin therapy and approaches to overcoming them. Diabetes Obes Metab. 2018 Mar;20(3):488-496. doi: 10.1111/dom.13132. Epub 2017 Nov 22. — View Citation

Weng J. Short-term intensive insulin therapy could be the preferred option for new onset Type 2 diabetes mellitus patients with HbA1c > 9. J Diabetes. 2017 Oct;9(10):890-893. doi: 10.1111/1753-0407.12581. Epub 2017 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	HbA1c in different conversion regimens	1,3,6 months
Secondary	The average blood glucose	The average blood glucose in different conversion regimens	1,3,6 months
Secondary	Fasting blood glucose	Fasting blood glucose in different conversion regimens	1,3,6 months
Secondary	Postprandial blood glucose	Postprandial blood glucose in different conversion regimens	1,3,6 months
Secondary	Incidence of hypoglycemia	Incidence of hypoglycemia in different conversion regimens	1,3,6 months
Secondary	Impact on body weight	Impact on body weight in different conversion regimens	1,3,6 months