InsulinNCT04833413
Regimen Switch After Intensive Insulin Therapy
An observational study of Insulin, run by Shanghai Zhongshan Hospital at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin
- What is being tested?
- Continuous intensive insulin therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with type 2 diabetes;
- Patients who started intensive insulin therapy during hospitalization
- Age ≥18 years old
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Zhongshan hospital
Shanghai, Shanghai Municipality, 200032
Xiao ying Li, MD, 13651913857, xiaoying_li@hotmail.com
Juan yu Fan, MD, 18101947845, fanyujuan22@sohu.com
- Recruiting
Department of Endocrinoogy, Zhongshan Hospital Fudan University
Shanghai
Yujuan Fan, 18101947845, fanyujuan22@sohu.com
About this study
Official title: Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes
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.
Read the detailed 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.
- Conditions
- Insulin
- Being tested
- Continuous intensive insulin therapy
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous intensive insulin therapyDrug
Also called Premixed insulin therapy, Basic insulin therapy, Oral hypoglycemic drug therapy
After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge
| Study group | Role | What they receive |
|---|---|---|
| Continue intensive treatment group | Patients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
HbA1c in different conversion regimens
Measured: 1，3，6 months
Secondary outcomes (5)
The average blood glucose
The average blood glucose in different conversion regimens
Measured: 1，3，6 months
Fasting blood glucose
Fasting blood glucose in different conversion regimens
Measured: 1，3，6 months
Postprandial blood glucose
Postprandial blood glucose in different conversion regimens
Measured: 1，3，6 months
Incidence of hypoglycemia
Incidence of hypoglycemia in different conversion regimens
Measured: 1，3，6 months
Impact on body weight
Impact on body weight in different conversion regimens
Measured: 1，3，6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InsulinStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833413
- Sponsor's protocol ID
- ZSE-202104
- Status last verified
- Jun 2023
- First submitted
- 3 Apr 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical study Report may be shared
Publications
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.
PubMed 25825361Jin 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.
PubMed 25952532Weng 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.
PubMed 28661564Davies 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.
PubMed 30291106Bellido 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.
PubMed 26459273Mauricio 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.
PubMed 28251792Russell-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.
PubMed 29053215Bowering 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.
PubMed 28483786Lind 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.
PubMed 26512041American 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.
PubMed 33298426
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Regimen Switch After Intensive Insulin Therapy in Hospitalized Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04833413
- Acronym / sponsor ID
- ZSE-202104
- Conditions
- Insulin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continue intensive treatment group | – | Drug: Continuous intensive insulin therapyPatients with type 2 diabetes who continued intensive treatment within 6 months after hospital discharge |
| Premixed insulin treatment group | – | Drug: Continuous intensive insulin therapyPatients with type 2 diabetes who changed to premixed insulin within 6 months after hospital discharge |
| Basic insulin treatment group | – | Drug: Continuous intensive insulin therapyPatients with type 2 diabetes who changed to basic insulin treatment within 6 months after hospital discharge |
| Oral hypoglycemic drug treatment group | – | –Patients with type 2 diabetes who changed to oral hypoglycemic drug treatment within 6 months after hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes;
- Patients who started intensive insulin therapy during hospitalization
- Age ≥18 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous intensive insulin therapyAlso: Premixed insulin therapy, Basic insulin therapy, Oral hypoglycemic drug therapyAfter initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge | Drug | Basic insulin treatment group, Continue intensive treatment group, Premixed insulin treatment group |
Primary outcome
Change in HbA1c
Time frame: 1，3，6 months
HbA1c in different conversion regimens
5 secondary outcomes
The average blood glucose
Time frame: 1，3，6 months
Fasting blood glucose
Time frame: 1，3，6 months
Postprandial blood glucose
Time frame: 1，3，6 months
Incidence of hypoglycemia
Time frame: 1，3，6 months
Impact on body weight
Time frame: 1，3，6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Results publication: PubMed 25825361Home 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.
- Results publication: PubMed 25952532Jin 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.
- Results publication: PubMed 28661564Weng 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.
- Results publication: PubMed 30291106Davies 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.
- Results publication: PubMed 26459273Bellido 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.
- Results publication: PubMed 28251792Mauricio 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.
- Results publication: PubMed 29053215Russell-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.
- Results publication: PubMed 28483786Bowering 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.
- Results publication: PubMed 26512041Lind 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.
- Results publication: PubMed 33298426American 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.
- Individual participant dataSharing planned: Undecided. Clinical study Report may be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin, run by Shanghai Zhongshan Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao ying Li, MD (13651913857, xiaoying_li@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 1，3，6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833413, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.