Regimen Switch After Intensive Insulin Therapy

NCT04833413 | Unknown

• 1 other identifier: ZSE-202104
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Insulin

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  HbA1c in different conversion regimens

  1，3，6 months

Secondary Outcomes (5)

• The average blood glucose

  1，3，6 months

• Fasting blood glucose

  1，3，6 months

• Postprandial blood glucose

  1，3，6 months

• Incidence of hypoglycemia

  1，3，6 months

• Impact on body weight

  1，3，6 months

Study Arms (4)

Continue intensive treatment group

Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge

Drug: Continuous intensive insulin therapy

Premixed insulin treatment group

Patients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge

Drug: Continuous intensive insulin therapy

Basic insulin treatment group

Patients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge

Drug: Continuous intensive insulin therapy

Oral hypoglycemic drug treatment group

Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge

Interventions

Continuous intensive insulin therapy DRUG

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

Also known as: Premixed insulin therapy, Basic insulin therapy, Oral hypoglycemic drug therapy

Basic insulin treatment group; Continue intensive treatment group; Premixed insulin treatment group

Eligibility Criteria

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

Study Population

2021.4 -- 2022.6 Adult patients with type 2 diabetes admitted to the endocrinology department of a level-2 or higher hospital and initiated intensive insulin therapy during hospitalization

You may qualify if:

• Patients with type 2 diabetes;
• Patients who started intensive insulin therapy during hospitalization
• Age ≥18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (2)

Zhongshan hospital

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Department of Endocrinoogy, Zhongshan Hospital Fudan University

Shanghai, China

RECRUITING

Related Publications (10)

• 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 diabetes across three continents. Diabetes Res Clin Pract. 2015 May;108(2):350-9. doi: 10.1016/j.diabres.2015.01.030. Epub 2015 Jan 23.

  PMID: 25825361 RESULT

• 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 optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29.

  PMID: 25952532 RESULT

• 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.

  PMID: 28661564 RESULT

• 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 for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.

  PMID: 30291106 RESULT

• 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. doi: 10.2337/dc15-0160. Epub 2015 Oct 12.

  PMID: 26459273 RESULT

• 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(8):1155-1164. doi: 10.1111/dom.12927. Epub 2017 Apr 10.

  PMID: 28251792 RESULT

• 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.

  PMID: 29053215 RESULT

• 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):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.

  PMID: 28483786 RESULT

• 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 (MDI Liraglutide trial). BMJ. 2015 Oct 28;351:h5364. doi: 10.1136/bmj.h5364.

  PMID: 26512041 RESULT

• 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.

  PMID: 33298426 RESULT

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Xiao ying Li, MD

CONTACT

13651913857; xiaoying_li@hotmail.com

Ying Chen, MD

CONTACT

15351890068; baiyuan9873@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 6, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

CN (2)