Glucocorticoid Induced HyperglycemiaPhase 4NCT07599891
Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patients".
A Phase 4 study testing Degludec insulin and Glargine insulin in people with Glucocorticoid Induced Hyperglycemia, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions. Despite their efficacy, the use of GCs is associated with a variety of side effects, one of the immediate ones being the development of glucocorticoids… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glucocorticoid Induced Hyperglycemia
- What is being tested?
- Degludec insulin and Glargine insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2023to 31 Mar 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non pregnant adult patients
- with or without Type 2 diabetes
- above the age of 18 years
- on glucocorticoid dose equivalent to >20 mg and <160 mg prednisolone daily for any indication
- with glucocorticoid induced hyperglycemia (random blood glucose >200 mg/dl)
- who are requiring basal bolus insulin regimen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Safety and Efficacy of Insulin Glargine and Insulin Degludec in Glucocorticoid Induced Hyperglycemia in Hospitalized Patients
Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions. Despite their efficacy, the use of GCs is associated with a variety of side effects, one of the immediate ones being the development of glucocorticoids induced hyperglycemia.
GCs decrease peripheral insulin sensitivity, increase hepatic gluconeogenesis, trigger insulin resistance, as well as inhibit pancreatic insulin production.([1] It has been shown that acute and chronic hyperglycemia that are present in many cases in the hospital setting are important risk factors for prolonged hospital stays, infectious complications, poorer surgical outcomes, and increased mortality.
In-hospital glucocorticoid induced hyperglycemia is usually managed with optimization of oral anti-diabetic drugs and basal bolus insulin, which has been well established over sliding scale insulin as the preferred regimen for GIH. Through this study we aim to compare to different basal insulins, glargine and degludec in terms of their efficacy and safety (hypoglycemic events) in this setting.
Read the detailed description
This study protocol describes a randomized controlled trial conducted at Max Super Specialty Hospital to compare the safety and efficacy of insulin glargine and insulin degludec in the management of glucocorticoid-induced hyperglycemia (GIH) among hospitalized patients. The study is being undertaken as a DNB thesis in the Department of Endocrinology under the guidance of Dr. Ambrish Mithal and colleagues.
Glucocorticoids are widely used in hospitalized patients for inflammatory, autoimmune, respiratory, infectious, and malignant conditions. However, they commonly cause hyperglycemia by increasing insulin resistance, enhancing hepatic gluconeogenesis, promoting lipolysis and proteolysis, and impairing pancreatic beta-cell insulin secretion. Approximately 40-50% of hospitalized patients receiving steroids develop GIH, which is associated with poor clinical outcomes such as prolonged hospitalization, infections, delayed wound healing, intensive care admission, and increased mortality.
The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about 42-hour duration. Degludec is hypothesized to provide similar glycemic control with fewer hypoglycemic episodes because of its flatter and more stable pharmacokinetic profile.
The primary objective is to compare the efficacy of glargine and degludec in reducing mean glucose levels in patients with GIH. Secondary objectives include comparing the incidence of hypoglycemia and identifying predictors of glycemic control.
The study population includes non-pregnant adults above 18 years with type 2 diabetes or without diabetes who are admitted under Respiratory Medicine and are receiving glucocorticoids equivalent to more than 20 mg and less than 160 mg prednisolone daily. Patients already on basal insulin, those receiving steroids for less than 48 hours, pregnant patients, or patients with diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), or requiring insulin infusion are excluded.
A total of 112 patients (56 per group) will be enrolled and randomized using the SNOSE (Sequentially Numbered Opaque Sealed Envelope) method into either the insulin glargine or insulin degludec group. Both groups will receive the same rapid-acting bolus insulin (insulin aspart).
Insulin Protocol
The insulin regimen is based on body weight and baseline blood glucose levels:
0.5 units/kg/day for blood glucose <140 mg/dL 0.8 units/kg/day for blood glucose 141-200 mg/dL
1 unit/kg/day for blood glucose >200 mg/dL
Patients already on basal-bolus insulin at home receive 130% of their prior total daily dose.
The total insulin dose is divided into:
Basal insulin (40%) using either insulin glargine or insulin degludec administered at 10 AM, 10 PM, or both depending on glycemic profile.
Bolus insulin (60%) using insulin aspart distributed as:
15% before breakfast 20% before lunch 10% before evening snack 15% before dinner
Correctional insulin doses are added or reduced according to pre-meal glucose levels. For glucose above 200 mg/dL, additional insulin is administered incrementally, while doses are reduced for glucose below 100 mg/dL. Separate lower correction scales are used for patients with chronic liver disease (CLD) or chronic kidney disease (CKD) to minimize hypoglycemia risk.
Blood glucose monitoring is performed using both capillary blood glucose (CBG) testing and continuous glucose monitoring (CGM) before meals, at 10 AM and/or 10 PM, and occasionally at 2 AM. Insulin doses are adjusted daily according to hospital protocol.
Hypoglycemia is defined as blood glucose below 70 mg/dL. Mild hypoglycemia is greater than or equal to 54 mg/dl and below 70 mg/dl; and severe hypoglycemia will be defined as <54 mg/dl or hypoglycemia with severe symptoms and requiring third party assistance. It will be managed according to standardized hospital treatment protocols with repeat glucose monitoring every 15 minutes until recovery.
The study duration is 18 months, and outcomes assessed include mean glucose levels, time in range, glycemic variability, and hypoglycemic events over the first five days of steroid therapy.
- Conditions
- Glucocorticoid Induced Hyperglycemia
- Being tested
- Degludec insulin, Glargine insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degludec insulinDrug
Degludec was used as part of basal bolus insulin regimen in the experimental arm of this study. Glargine was used as active comparator.
Glargine insulinDrug
Glargine was used as part of basal bolus insulin regimen in the active comparator arm of this study.
| Study group | Role | What they receive |
|---|---|---|
| Degludec | Experimental | Degludec was used as a basal insulin against active comparator glargine. Receives: Drug: Degludec insulin |
| Glargine | Active comparator | Glargine is an established treatment for glucocorticoid induced hyperglycemia, hence was used as active comparator in this study. Receives: Drug: Glargine insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
basal insulin dose - on Day 1 and Day 5 of basal bolus treatment
Basal insulin dose measured in units on Day 1 and Day 5 of basal bolus treatment - expressed in IU
Measured: for 5 days while admitted to the hospital, from Day 1 of initiation of basal bolus insulin in hospital, to Day 5 of treatment
Bolus insulin dose on Day 1 and Day 5 of treatment
Insulin dose of bolus insulin - on Day 1 and Day 5 of treatment , expressed in IU.
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl
Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time in range
Time in range - as measured on continuous glucose monitor - in percentage
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time above range
Time above range - as measured on continuous glucose monitor - expressed in percentage
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage
Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Change in Mean amplitude of glycemic excursions (MAGE) - expressed in mg/dl
MAGE the amplitude of glucose variations over time, calculated using Continuous glucose monitoring data in open source software known as EasyGV - expressed in mg/dl
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Change in basal insulin, bolus insulin, and total insulin doses from Day 1 to Day 5 in both groups
The change in basal insulin, bolus insulin and total insulin dose from Day 1 to Day 5 will be calculated for both glargine and degludec group,
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Secondary outcomes (3)
Incidences of fasting hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring fasting state (early morning, between 5-6 am) - expressed in mg/dl
Fasting Hypoglycemia as measured by glucometer (capillary blood glucose) will be defined as - mild - less than 70 mg/dl but more than or equal to 54 mg/dl; severe -- less than 54 mg/dl, or requirement of third person assistance in correcting hypoglycemia and hypoglycemic symptoms, in the fasting state. Expressed in mg/dl.
Measured: for 5 days while admitted in hospital during the clinical trial , from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Incidences of non -fasting (random) hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring in non-fasting states
Non fasting hypoglycemia (random hypoglycemia, in mg/dl) as measured by glucometer (capillary blood glucose) will be defined as - mild - less than 70 mg/dl but more than or equal to 54; severe - less than 54 mg/dl, or requirement of third person assistance in correcting hypoglycemia and hypoglycemic symptoms . It will be expressed as mg/dl.
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time below range
Time below range, expressed in percentage, as measured by continuous glucose monitor, on Day 1 and Day 5 of basal bolus treatment
Measured: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Sep 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid Induced HyperglycemiaStudies 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
- Model description
- Hospitalized, non pregnant adult patients (above 18 years of age) with or without diabetes, receiving glucocortcoids (prednisolone dose equivalent of 20-160 mg per day) and having glucocorticoid induced hyperglycemia and requiring basal bolus insulin for the management of the same, were randomized to two groups. One group received glargine, and the other degludec insulin as the basal insulin. Both groups received insulin aspart as the bolus. Weight based insulin dosing was done as per study protocol. Patients from both groups were followed for five days, and blood glucose monitoring was done using capillary blood glucose as well as continuous glucose monitoring
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599891
- Sponsor's protocol ID
- :MIME/DNB/SKT-2023-0987
- Status last verified
- May 2026
- First submitted
- 23 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Safety and Efficacy of Insulin Glargine and Insulin Degludec in Glucocorticoid Induced Hyperglycemia in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT07599891
- Acronym / sponsor ID
- :MIME/DNB/SKT-2023-0987
- Conditions
- Glucocorticoid Induced Hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 May 2026 (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.
Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions. Despite their efficacy, the use of GCs is associated with a variety of side effects, one of the immediate ones being the development of glucocorticoids induced hyperglycemia.
GCs decrease peripheral insulin sensitivity, increase hepatic gluconeogenesis, trigger insulin resistance, as well as inhibit pancreatic insulin production.([1] It has been shown that acute and chronic hyperglycemia that are present in many cases in the hospital setting are important risk factors for prolonged hospital stays, infectious complications, poorer surgical outcomes, and increased mortality.
In-hospital glucocorticoid induced hyperglycemia is usually managed with optimization of oral anti-diabetic drugs and basal bolus insulin, which has been well established over sliding scale insulin as the preferred regimen for GIH. Through this study we aim to compare to different basal insulins, glargine and degludec in terms of their efficacy and safety (hypoglycemic events) in this setting.
Detailed description
This study protocol describes a randomized controlled trial conducted at Max Super Specialty Hospital to compare the safety and efficacy of insulin glargine and insulin degludec in the management of glucocorticoid-induced hyperglycemia (GIH) among hospitalized patients. The study is being undertaken as a DNB thesis in the Department of Endocrinology under the guidance of Dr. Ambrish Mithal and colleagues.
Glucocorticoids are widely used in hospitalized patients for inflammatory, autoimmune, respiratory, infectious, and malignant conditions. However, they commonly cause hyperglycemia by increasing insulin resistance, enhancing hepatic gluconeogenesis, promoting lipolysis and proteolysis, and impairing pancreatic beta-cell insulin secretion. Approximately 40-50% of hospitalized patients receiving steroids develop GIH, which is associated with poor clinical outcomes such as prolonged hospitalization, infections, delayed wound healing, intensive care admission, and increased mortality.
The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about 42-hour duration. Degludec is hypothesized to provide similar glycemic control with fewer hypoglycemic episodes because of its flatter and more stable pharmacokinetic profile.
The primary objective is to compare the efficacy of glargine and degludec in reducing mean glucose levels in patients with GIH. Secondary objectives include comparing the incidence of hypoglycemia and identifying predictors of glycemic control.
The study population includes non-pregnant adults above 18 years with type 2 diabetes or without diabetes who are admitted under Respiratory Medicine and are receiving glucocorticoids equivalent to more than 20 mg and less than 160 mg prednisolone daily. Patients already on basal insulin, those receiving steroids for less than 48 hours, pregnant patients, or patients with diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), or requiring insulin infusion are excluded.
A total of 112 patients (56 per group) will be enrolled and randomized using the SNOSE (Sequentially Numbered Opaque Sealed Envelope) method into either the insulin glargine or insulin degludec group. Both groups will receive the same rapid-acting bolus insulin (insulin aspart).
Insulin Protocol
The insulin regimen is based on body weight and baseline blood glucose levels:
0.5 units/kg/day for blood glucose <140 mg/dL 0.8 units/kg/day for blood glucose 141-200 mg/dL
1 unit/kg/day for blood glucose >200 mg/dL
Patients already on basal-bolus insulin at home receive 130% of their prior total daily dose.
The total insulin dose is divided into:
Basal insulin (40%) using either insulin glargine or insulin degludec administered at 10 AM, 10 PM, or both depending on glycemic profile.
Bolus insulin (60%) using insulin aspart distributed as:
15% before breakfast 20% before lunch 10% before evening snack 15% before dinner
Correctional insulin doses are added or reduced according to pre-meal glucose levels. For glucose above 200 mg/dL, additional insulin is administered incrementally, while doses are reduced for glucose below 100 mg/dL. Separate lower correction scales are used for patients with chronic liver disease (CLD) or chronic kidney disease (CKD) to minimize hypoglycemia risk.
Blood glucose monitoring is performed using both capillary blood glucose (CBG) testing and continuous glucose monitoring (CGM) before meals, at 10 AM and/or 10 PM, and occasionally at 2 AM. Insulin doses are adjusted daily according to hospital protocol.
Hypoglycemia is defined as blood glucose below 70 mg/dL. Mild hypoglycemia is greater than or equal to 54 mg/dl and below 70 mg/dl; and severe hypoglycemia will be defined as <54 mg/dl or hypoglycemia with severe symptoms and requiring third party assistance. It will be managed according to standardized hospital treatment protocols with repeat glucose monitoring every 15 minutes until recovery.
The study duration is 18 months, and outcomes assessed include mean glucose levels, time in range, glycemic variability, and hypoglycemic events over the first five days of steroid therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hospitalized, non pregnant adult patients (above 18 years of age) with or without diabetes, receiving glucocortcoids (prednisolone dose equivalent of 20-160 mg per day) and having glucocorticoid induced hyperglycemia and requiring basal bolus insulin for the management of the same, were randomized to two groups. One group received glargine, and the other degludec insulin as the basal insulin. Both groups received insulin aspart as the bolus. Weight based insulin dosing was done as per study protocol. Patients from both groups were followed for five days, and blood glucose monitoring was done using capillary blood glucose as well as continuous glucose monitoring
| Arm | Type | Receives |
|---|---|---|
| Degludec | Experimental | Drug: Degludec insulinDegludec was used as a basal insulin against active comparator glargine. |
| Glargine | Active comparator | Drug: Glargine insulinGlargine is an established treatment for glucocorticoid induced hyperglycemia, hence was used as active comparator in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Non pregnant adult patients
- with or without Type 2 diabetes
- above the age of 18 years
- on glucocorticoid dose equivalent to >20 mg and <160 mg prednisolone daily for any indication
- with glucocorticoid induced hyperglycemia (random blood glucose >200 mg/dl)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Degludec insulinDegludec was used as part of basal bolus insulin regimen in the experimental arm of this study. Glargine was used as active comparator. | Drug | Degludec |
| Glargine insulinGlargine was used as part of basal bolus insulin regimen in the active comparator arm of this study. | Drug | Glargine |
Primary outcome
basal insulin dose - on Day 1 and Day 5 of basal bolus treatment
Time frame: for 5 days while admitted to the hospital, from Day 1 of initiation of basal bolus insulin in hospital, to Day 5 of treatment
Basal insulin dose measured in units on Day 1 and Day 5 of basal bolus treatment - expressed in IU
Bolus insulin dose on Day 1 and Day 5 of treatment
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Insulin dose of bolus insulin - on Day 1 and Day 5 of treatment , expressed in IU.
Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl
Time in range
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time in range - as measured on continuous glucose monitor - in percentage
Time above range
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time above range - as measured on continuous glucose monitor - expressed in percentage
Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage
Change in Mean amplitude of glycemic excursions (MAGE) - expressed in mg/dl
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
MAGE the amplitude of glucose variations over time, calculated using Continuous glucose monitoring data in open source software known as EasyGV - expressed in mg/dl
Change in basal insulin, bolus insulin, and total insulin doses from Day 1 to Day 5 in both groups
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
The change in basal insulin, bolus insulin and total insulin dose from Day 1 to Day 5 will be calculated for both glargine and degludec group,
3 secondary outcomes
Incidences of fasting hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring fasting state (early morning, between 5-6 am) - expressed in mg/dl
Time frame: for 5 days while admitted in hospital during the clinical trial , from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Incidences of non -fasting (random) hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring in non-fasting states
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin
Time below range
Time frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Degludec insulin and Glargine insulin in people with Glucocorticoid Induced Hyperglycemia, run by Max Healthcare Insititute Limited at 1 site in India.
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 6 inclusion and 0 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 20 May 2026. 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 India. 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?
basal insulin dose - on Day 1 and Day 5 of basal bolus treatment (time frame: for 5 days while admitted to the hospital, from Day 1 of initiation of basal bolus insulin in hospital, to Day 5 of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.