Type 2 DiabetesPhase 4SITAGLAR-HNCT05579119
SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)
A Phase 4 study testing Sitagliptin 100mg, Glargine and Lispro in people with Type 2 Diabetes, run by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
In noncritically hospitalized patients, hyperglycemia (defined as blood glucose [BG] levels >140 mg/dL) is a common, serious, and costly healthcare problem. On the other hand, the treatment of hyperglycemia is associated with decreased mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin 100mg, Glargine and Lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jul 2022to 24 Aug 2023
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or female medical non-ICU patients aged 18 - 70 years.
- A known history of type 2 diabetes > 3 months, receiving either diet alone, oral antidiabetic agents (excluding DPP4 inhibitors), or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- Subjects with BG >180 mg and < 400 mg/dL at the time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
- Written informed consent.
Who cannot join
- Age < 18 or > 70 years.
- Subjects with increased BG concentration but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes.
- Patients with a history of diabetic ketoacidosis or hyperosmolar state.
- Acute critical illness or coronary artery bypass graft (CABG) surgery is expected to require admission to a critical care unit.
- Subjects with gastrointestinal obstruction, adynamic ileus, or those expected to require gastrointestinal suction.
Show all 14Show fewer
- Unable to take oral food or medications.
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with significant hepatic disease (Child-Pugh score B or C) or impaired renal function (GFR < 50 ml/min).
- Treatment with oral or injectable corticosteroid.
- Mental condition renders the subject unable to understand the study's nature, scope, and possible consequences.
- Female subjects are pregnant or breastfeeding at the time of enrollment into the study.
- Hypersensitivity to sitagliptin or another contraindication to DPP4 inhibitors.
- Subject unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
División de Investigación en Salud, Hospital de Especialidades, Centro Médico Nacional "La Raza", IMSS
Mexico City, 02990
About this study
Official title: Efficacy and Safety of Sitagliptin and Glargine Compared to a Basal-plus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes
In noncritically hospitalized patients, hyperglycemia (defined as blood glucose [BG] levels >140 mg/dL) is a common, serious, and costly healthcare problem. On the other hand, the treatment of hyperglycemia is associated with decreased mortality and morbidity. Therefore, clinical guidelines from professional organizations recommend using subcutaneous insulin as the preferred therapy in hospitalized patients in a non-intensive care unit setting (target glucose range 100 - 180 mg/dl). The most recommended regimen is basal-bolus insulin therapy, although this regimen requires multiple daily insulin injections and is associated with a significant risk of hypoglycemia (reported in up to 32%). Thus, a more straightforward regimen that results in similar glycemic efficacy to basal-bolus insulin with less risk of hypoglycemia could improve care for this group of patients.
The basal-plus insulin regimen consists of a daily dose of basal insulin with supplemental (corrective) doses of rapid-acting insulin analogue before meals. This has similar efficacy and safety as the basal-bolus regimen. However, the basal-plus scheme does not provide prandial coverage of insulin.
Read more
In another vein, dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of oral glucose-lowering agents that reduce the breakdown of endogenous glucagon-like peptide-1 (GLP-1), stimulating insulin secretion in a glucose-dependent manner. Some clinical trials have demonstrated that DPP-4 inhibitors, in combination with insulin, result in similar improvement in glycemic control and lower rates of hypoglycemia compared to basal-bolus insulin regimens.
For the above, using a long-acting insulin analogue with a DPP-4 inhibitor could provide better glycemic control basal and prandial, and this scheme could represent an alternative to using a basal-plus regimen alone.
In the present study, the investigators will conduct a prospective randomized clinical trial (RCT) to compare the DPP-4 inhibitor, sitagliptin, combined with basal-plus insulin therapy and basal-plus insulin scheme alone in non-critical hospitalized patients.
Read the detailed description
Patients with a known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin or a basal-plus regimen with glargine. Both groups will receive correction doses of rapid-acting insulin lispro in the presence of hyperglycemia (BG >180 mg/dL) per sliding scale. The overall hypothesis is that treatment with sitagliptin in combination with basal insulin will result in better glycemic control and a lower frequency of hypoglycemic events than treatment with a basal-plus insulin regimen in patients with type 2 diabetes in the hospital setting.
68 subjects with type 2 diabetes will be recruited for this study.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin 100mg, Glargine, Lispro
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin 100mgDrug
Also called Januvia
Sitagliptin 100 mg po once daily.
GlargineDrug
Also called Lantus
Glargine once daily.
LisproDrug
Also called Humalog
Correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI).
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin + glargine | Experimental | Sitagliptin and glargine once daily + correction doses of lispro if needed. Receives: Drug: Sitagliptin 100mg; Drug: Glargine; Drug: Lispro |
| Basal-plus | Active comparator | Glargine once daily plus correction doses of lispro if needed. Receives: Drug: Glargine; Drug: Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the mean daily blood glucose levels during hospital
Change of the mean daily blood glucose during the hospitalization between the groups
Measured: During hospitalization
Secondary outcomes (5)
Percentage of blood glucose readings in 100-180 mg/dL range
Percentage of BG readings in the desired range of 100-180 mg/dl out of all avaialble BG readings.
Measured: During hospitalization, up to 10 days
Dose of Insulin
Average daily amount of insulin used.
Measured: During hospitalization, up to 10 days
Incidence of hypoglycemia (BG <70 mg/dL)
Number of BG readings <70 mg/dL in each group.
Measured: During hospitalization, up to 10 days
Percentage of blood glucose reading >180 mg/dL
Percentage of BG reading >180 mg/dL
Measured: During hospitalization, up to 10 days
Mean length of stay in days in the hospital among different groups
The duration of stay in days in the hospital between the two groups is calculated and mean number of days is measured.
Measured: During hospitalization, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start6 Jul 2022
- Primary completion14 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
- Sponsor type
- University, hospital or other
- Collaborators
- National Polytechnic Institute, Mexico
- Responsible party
- Principal investigator, Abraham Edgar Gracia-Ramos, Centro Medico Nacional La Raza, IMSS
- Investigators
- Abraham Edgar Gracia-Ramos, MD, MSc, Principal investigator, Hospital General, Centro Médico Nacional "La Raza", IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579119
- Sponsor's protocol ID
- R-2021-3501-078
- Acronym
- SITAGLAR-H
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gracia-Ramos AE. Role of incretin-based therapy in hospitalized patients with type 2 diabetes. J Diabetes Investig. 2020 Mar;11(2):508-509. doi: 10.1111/jdi.13130. Epub 2019 Sep 17.
PubMed 31529777Gracia-Ramos AE, Carretero-Gomez J, Mendez CE, Carrasco-Sanchez FJ. Evidence-based therapeutics for hyperglycemia in hospitalized noncritically ill patients. Curr Med Res Opin. 2022 Jan;38(1):43-53. doi: 10.1080/03007995.2021.1997288. Epub 2021 Nov 22.
PubMed 34694181Gracia-Ramos AE, Cruz-Dominguez MP, Madrigal-Santillan EO. Incretin-based therapy for glycemic control of hospitalized patients with type 2 diabetes: a systematic review. Rev Clin Esp (Barc). 2022 Mar;222(3):180-189. doi: 10.1016/j.rceng.2021.09.003. Epub 2021 Dec 4.
PubMed 34872879Umpierrez GE, Gianchandani R, Smiley D, Jacobs S, Wesorick DH, Newton C, Farrokhi F, Peng L, Reyes D, Lathkar-Pradhan S, Pasquel F. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care. 2013 Nov;36(11):3430-5. doi: 10.2337/dc13-0277. Epub 2013 Jul 22.
PubMed 23877988Pasquel FJ, Gianchandani R, Rubin DJ, Dungan KM, Anzola I, Gomez PC, Peng L, Hodish I, Bodnar T, Wesorick D, Balakrishnan V, Osei K, Umpierrez GE. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):125-133. doi: 10.1016/S2213-8587(16)30402-8. Epub 2016 Dec 8.
PubMed 27964837Vellanki P, Rasouli N, Baldwin D, Alexanian S, Anzola I, Urrutia M, Cardona S, Peng L, Pasquel FJ, Umpierrez GE; Linagliptin Inpatient Research Group. Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial. Diabetes Obes Metab. 2019 Apr;21(4):837-843. doi: 10.1111/dom.13587. Epub 2018 Dec 17.
PubMed 30456796Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.
PubMed 28405346Guardado-Mendoza R, Garcia-Magana MA, Martinez-Navarro LJ, Macias-Cervantes HE, Aguilar-Guerrero R, Suarez-Perez EL, Aguilar-Garcia A. Effect of linagliptin plus insulin in comparison to insulin alone on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 infection. Sci Rep. 2022 Jan 11;12(1):536. doi: 10.1038/s41598-021-04511-1.
PubMed 35017617Gracia-Ramos AE, Cruz-Dominguez MDP, Madrigal-Santillan EO, Rojas-Martinez R, Morales-Gonzalez JA, Morales-Gonzalez A, Hernandez-Espinoza M, Vargas-Penafiel J, Tapia-Gonzalez MLA. Efficacy and safety of sitagliptin with basal-plus insulin regimen versus insulin alone in non-critically ill hospitalized patients with type 2 diabetes: SITA-PLUS hospital trial. J Diabetes Complications. 2024 May;38(5):108742. doi: 10.1016/j.jdiacomp.2024.108742. Epub 2024 Apr 3.
PubMed 38581842
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sitagliptin and Glargine Compared to a Basal-plus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05579119
- Acronym / sponsor ID
- SITAGLAR-H / R-2021-3501-078
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro SocialUniversity, hospital or other
- Collaborators
- National Polytechnic Institute, Mexico
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 13 Oct 2022 (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.
In noncritically hospitalized patients, hyperglycemia (defined as blood glucose [BG] levels >140 mg/dL) is a common, serious, and costly healthcare problem. On the other hand, the treatment of hyperglycemia is associated with decreased mortality and morbidity. Therefore, clinical guidelines from professional organizations recommend using subcutaneous insulin as the preferred therapy in hospitalized patients in a non-intensive care unit setting (target glucose range 100 - 180 mg/dl). The most recommended regimen is basal-bolus insulin therapy, although this regimen requires multiple daily insulin injections and is associated with a significant risk of hypoglycemia (reported in up to 32%). Thus, a more straightforward regimen that results in similar glycemic efficacy to basal-bolus insulin with less risk of hypoglycemia could improve care for this group of patients.
The basal-plus insulin regimen consists of a daily dose of basal insulin with supplemental (corrective) doses of rapid-acting insulin analogue before meals. This has similar efficacy and safety as the basal-bolus regimen. However, the basal-plus scheme does not provide prandial coverage of insulin.
In another vein, dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of oral glucose-lowering agents that reduce the breakdown of endogenous glucagon-like peptide-1 (GLP-1), stimulating insulin secretion in a glucose-dependent manner. Some clinical trials have demonstrated that DPP-4 inhibitors, in combination with insulin, result in similar improvement in glycemic control and lower rates of hypoglycemia compared to basal-bolus insulin regimens.
For the above, using a long-acting insulin analogue with a DPP-4 inhibitor could provide better glycemic control basal and prandial, and this scheme could represent an alternative to using a basal-plus regimen alone.
In the present study, the investigators will conduct a prospective randomized clinical trial (RCT) to compare the DPP-4 inhibitor, sitagliptin, combined with basal-plus insulin therapy and basal-plus insulin scheme alone in non-critical hospitalized patients.
Detailed description
Patients with a known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin or a basal-plus regimen with glargine. Both groups will receive correction doses of rapid-acting insulin lispro in the presence of hyperglycemia (BG >180 mg/dL) per sliding scale. The overall hypothesis is that treatment with sitagliptin in combination with basal insulin will result in better glycemic control and a lower frequency of hypoglycemic events than treatment with a basal-plus insulin regimen in patients with type 2 diabetes in the hospital setting.
68 subjects with type 2 diabetes will be recruited for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin + glargine | Experimental | Drug: Sitagliptin 100mg, Drug: Glargine, Drug: LisproSitagliptin and glargine once daily + correction doses of lispro if needed. |
| Basal-plus | Active comparator | Drug: Glargine, Drug: LisproGlargine once daily plus correction doses of lispro if needed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or female medical non-ICU patients aged 18 - 70 years.
- A known history of type 2 diabetes > 3 months, receiving either diet alone, oral antidiabetic agents (excluding DPP4 inhibitors), or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- Subjects with BG >180 mg and < 400 mg/dL at the time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
- Written informed consent.
Key exclusion criteria (14 listed)
- Age < 18 or > 70 years.
- Subjects with increased BG concentration but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes.
- Patients with a history of diabetic ketoacidosis or hyperosmolar state.
- Acute critical illness or coronary artery bypass graft (CABG) surgery is expected to require admission to a critical care unit.
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 |
|---|---|---|
| Sitagliptin 100mgAlso: JanuviaSitagliptin 100 mg po once daily. | Drug | Sitagliptin + glargine |
| GlargineAlso: LantusGlargine once daily. | Drug | Basal-plus, Sitagliptin + glargine |
| LisproAlso: HumalogCorrectional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI). | Drug | Basal-plus, Sitagliptin + glargine |
Primary outcome
Change of the mean daily blood glucose levels during hospital
Time frame: During hospitalization
Change of the mean daily blood glucose during the hospitalization between the groups
5 secondary outcomes
Percentage of blood glucose readings in 100-180 mg/dL range
Time frame: During hospitalization, up to 10 days
Dose of Insulin
Time frame: During hospitalization, up to 10 days
Incidence of hypoglycemia (BG <70 mg/dL)
Time frame: During hospitalization, up to 10 days
Percentage of blood glucose reading >180 mg/dL
Time frame: During hospitalization, up to 10 days
Mean length of stay in days in the hospital among different groups
Time frame: During hospitalization, up to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 31529777Gracia-Ramos AE. Role of incretin-based therapy in hospitalized patients with type 2 diabetes. J Diabetes Investig. 2020 Mar;11(2):508-509. doi: 10.1111/jdi.13130. Epub 2019 Sep 17.
- Background: PubMed 34694181Gracia-Ramos AE, Carretero-Gomez J, Mendez CE, Carrasco-Sanchez FJ. Evidence-based therapeutics for hyperglycemia in hospitalized noncritically ill patients. Curr Med Res Opin. 2022 Jan;38(1):43-53. doi: 10.1080/03007995.2021.1997288. Epub 2021 Nov 22.
- Background: PubMed 34872879Gracia-Ramos AE, Cruz-Dominguez MP, Madrigal-Santillan EO. Incretin-based therapy for glycemic control of hospitalized patients with type 2 diabetes: a systematic review. Rev Clin Esp (Barc). 2022 Mar;222(3):180-189. doi: 10.1016/j.rceng.2021.09.003. Epub 2021 Dec 4.
- Background: PubMed 23877988Umpierrez GE, Gianchandani R, Smiley D, Jacobs S, Wesorick DH, Newton C, Farrokhi F, Peng L, Reyes D, Lathkar-Pradhan S, Pasquel F. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care. 2013 Nov;36(11):3430-5. doi: 10.2337/dc13-0277. Epub 2013 Jul 22.
- Background: PubMed 27964837Pasquel FJ, Gianchandani R, Rubin DJ, Dungan KM, Anzola I, Gomez PC, Peng L, Hodish I, Bodnar T, Wesorick D, Balakrishnan V, Osei K, Umpierrez GE. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):125-133. doi: 10.1016/S2213-8587(16)30402-8. Epub 2016 Dec 8.
- Background: PubMed 30456796Vellanki P, Rasouli N, Baldwin D, Alexanian S, Anzola I, Urrutia M, Cardona S, Peng L, Pasquel FJ, Umpierrez GE; Linagliptin Inpatient Research Group. Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial. Diabetes Obes Metab. 2019 Apr;21(4):837-843. doi: 10.1111/dom.13587. Epub 2018 Dec 17.
- Background: PubMed 28405346Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.
- Background: PubMed 35017617Guardado-Mendoza R, Garcia-Magana MA, Martinez-Navarro LJ, Macias-Cervantes HE, Aguilar-Guerrero R, Suarez-Perez EL, Aguilar-Garcia A. Effect of linagliptin plus insulin in comparison to insulin alone on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 infection. Sci Rep. 2022 Jan 11;12(1):536. doi: 10.1038/s41598-021-04511-1.
- Derived from this study: PubMed 38581842Gracia-Ramos AE, Cruz-Dominguez MDP, Madrigal-Santillan EO, Rojas-Martinez R, Morales-Gonzalez JA, Morales-Gonzalez A, Hernandez-Espinoza M, Vargas-Penafiel J, Tapia-Gonzalez MLA. Efficacy and safety of sitagliptin with basal-plus insulin regimen versus insulin alone in non-critically ill hospitalized patients with type 2 diabetes: SITA-PLUS hospital trial. J Diabetes Complications. 2024 May;38(5):108742. doi: 10.1016/j.jdiacomp.2024.108742. Epub 2024 Apr 3.
- Individual participant dataSharing planned: No
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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.
Abraham Edgar Gracia-Ramos, MD, MSc principal investigator
Hospital General, Centro Médico Nacional "La Raza", IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin 100mg, Glargine and Lispro in people with Type 2 Diabetes, run by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the mean daily blood glucose levels during hospital (time frame: During hospitalization). 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 NCT05579119, which also lists 9 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 26 Sep 2023.