Diabetes MellitusPhase 4NCT04416269
Oral Anti Diabetic Agents in the Hospital
A Phase 4 study testing Oral Anti-diabetes Drugs alone, Basal bolus insulin and Supplemental insulin in people with Diabetes Mellitus, run by Emory University at 3 sites in United States.
Trial summary
This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Oral Anti-diabetes Drugs alone, Basal bolus insulin and Supplemental insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Aug 2020to 11 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age 18-80 years admitted to a general medicine and surgery services
- Known history of T2D receiving OADs either as monotherapy or in combination therapy
- Admission BG < 250 mg/dl or randomization BG <250 mg/dl and not receiving basal insulin
- Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c <7.5% within the past three months
- HbA1c <10%
Who cannot join
- No known history of diabetes
- Laboratory evidence of diabetic ketoacidosis
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)
- Meeting any exclusion criteria based on specific contraindications to their home oral therapy
- Acute critical illness or cardiac surgery expected to require admission to a critical care unit
- Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction
Show all 12Show fewer
- Medical or surgical patients expected to be kept NPO for >24-48 hours after admission or after completion of surgical procedure
- Impaired renal function (eGFR <30 ml/min)
- Current treatment with oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the nature and scope of the study
- Female subjects who are pregnant or breastfeeding at time of enrollment in the study
- New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of admission
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Grady Memorial Hospital
Atlanta, Georgia, 30322
About this study
Official title: Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes
This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose (BG) concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Read the detailed description
Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Improving glycemic control has been shown to improve length of stay, multi-organ failure, systemic infections, as well as short- and long-term mortality. Clinical guidelines from professional organizations recommend the use of subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical and surgical patients with T2D. This approach, however, is labor intensive requiring multiple daily insulin injections, costly, and associated with significant risk of iatrogenic hypoglycemia
Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the lack of safety and efficacy data from randomized controlled trials, clinical guidelines recommend stopping OADs during hospitalization. The current clinical guidelines have raised concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid retention and worsening of heart failure with thiazolidinediones, and risk of metformin-associated lactic acidosis in patients with severe renal impairment. However, several observational studies have reported that the use of OADs results in similar glycemic control without increased risk of complications compared to insulin regimens. A recent observational study that included 17,325 hospitalized patients with T2D, found that patients treated with OADs had similar glycemic control without differences in complications and no increase in rates of hypoglycemia compared to those treated with insulin.
This study will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in hospital patients with T2D. For a subset of participants, a CGM device will be placed for the duration of the study to assess parameters of glycemic control and hypoglycemia.
- Conditions
- Diabetes Mellitus
- Being tested
- Oral Anti-diabetes Drugs alone, Basal bolus insulin, Supplemental insulin, Continuous glucose monitoring (CGM)
- Keywords
- Hyperglycemia, Insulin therapy, Oral therapy, Basal bolus therapy, Mean daily blood glucose, Hospitalization
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Anti-diabetes Drugs aloneDrug
Also called metformin, sulfonylureas, pioglitazone, dipeptidyl peptidase-4 (DPP-4) inhibitors
OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.
Basal bolus insulinDrug
Also called glargine, detemir
Basal insulin with glargine or detemir will be used as per the hospital formulary.
Supplemental insulinDrug
Also called Humalog, Novolog
Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG >140 mg/dl.
Continuous glucose monitoring (CGM)Device
Also called Dexcom
A subset of participants will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.
The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Oral Anti-diabetes Drugs (OADs) alone | Experimental | OADs will be continued at same outpatient dosage unless contraindicated Receives: Drug: Oral Anti-diabetes Drugs alone; Drug: Supplemental insulin; Device: Continuous glucose monitoring (CGM) |
| Basal bolus insulin | Active comparator | Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission. Receives: Drug: Basal bolus insulin; Drug: Supplemental insulin; Device: Continuous glucose monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Blood Glucose (BG) Concentration
Mean daily BG concentration is compared between OADs and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Measured: During hospital stay (up to 10 days)
Secondary outcomes (24)
Number of Mild Hypoglycemic Events
Mild hypoglycemic events are defined as BG <70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continuous glucose monitoring (CGM).
Measured: During hospital stay (up to 10 days)
Number of Clinically Significant Hypoglycemic Events
Clinically significant hypoglycemic events are defined as BG <54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
Measured: During hospital stay (up to 10 days)
Number of Severe Hypoglycemic Severe (<40 mg/dl) Events
Severe hypoglycemic events are defined as BG <40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
Measured: During hospital stay (up to 10 days)
Percent of Blood Glucose Values Within Target Range Without Hypoglycemia
The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia is compared between study arms.
Measured: During hospital stay (up to 10 days)
Number of Episodes of Hyperglycemia After the First Day of Treatment
The number of episodes of hyperglycemia (BG > 280 mg/dl) after the first day of treatment is compared between study arms.
Measured: During hospital stay (up to 10 days)
Units Per Day of Insulin
The units of insulin administered per day is compared between study arms.
Measured: During hospital stay (up to 10 days)
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
The number of participants using specific oral antidiabetic drugs (OADs) during hospitalization use was recorded. Some participants used more than one OAD.
Measured: During hospital stay (up to 10 days)
Number of Patients on OADs Requiring Insulin Rescue Therapy
The number of patients on OADs requiring insulin rescue therapy was recorded
Measured: During hospital stay (up to 10 days)
Number of Episodes of Treatment Failure
Treatment failure is defined as mean daily BG > 240 mg/dl or 3 consecutive BG > 240 mg/dl.
Measured: During hospital stay (up to 10 days)
Glycemic Variability in Participants Receiving CGM Monitoring
Glycemic variability is measured using the coefficient of variation
Measured: During hospital stay (up to 10 days)
Percentage of Time Above BG Target Range (>180 mg/dl) in Participants Receiving CGM Monitoring
The percentage of time above BG target range (>180 mg/dl) is assessed in participants receiving CGM monitoring.
Measured: During hospital stay (up to 10 days)
Percentage of Time in BG Target Range (70-180 mg/dl) in Participants Receiving CGM Monitoring
The percentage of time in the BG target range (70-180 mg/dl) is assessed in participants receiving CGM monitoring.
Measured: During hospital stay (up to 10 days)
Percentage of Time Below BG Target Range (BG <70 mg/dl) in Participants Receiving CGM Monitoring
The percentage of time below BG target range (BG <70 mg/dl) is assessed in participants receiving CGM monitoring.
Measured: During hospital stay (up to 10 days)
Number of Hospital Complications
Hospital complications are assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality.
Measured: During hospital stay (up to 10 days)
In-hospital Mortality
In-hospital mortality is compared between study arms.
Measured: During hospital stay (up to 10 days)
Number of Individual Hospital Complications
Number of individual hospital complications is compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest.
Measured: Up to 40 days (hospital stay plus 30 days after discharge)
Hospital Costs
Total hospital costs will be compared between study arms.
Measured: During hospital stay (up to 10 days)
Length of Hospital Stay
Length of hospital stay, in days, is compared between study arms. Participants were engaged in study activities for up to 10 days during hospitalization and the total number of days of hospitalization was obtained from medical records.
Measured: During hospital stay (up to 10 days)
Costs for Diabetes Specific Therapies
Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms.
Measured: During hospital stay (up to 10 days)
Number of Hospital Re-admissions
Number of hospital re-admissions within 30 days of hospital discharge are compared between study arms.
Measured: within 30 days of hospital discharge
Number of Emergency Room Visits
Number of emergency room visits within 30 days of hospital discharge is compared between study arms.
Measured: within 30 days of hospital discharge
Number of Participants Requiring ICU Care
The number of participants transferred to the ICU is compared between study arms.
Measured: During hospital stay (up to 10 days)
Nursing Antihyperglycemic Drug Preference Survey
The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey. The number of nurses agreeing with each item are presented here.
Measured: Day of hospital discharge (up to 10 days)
Patient Antihyperglycemic Drug Preference Survey
Participants completed a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. The number of participants agreeing with the survey item are presented here. A summary score is not calculated for this qualitative survey.
Measured: Day of hospital discharge (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 posted4 Jun 2020
- Study start7 Aug 2020
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Why it stopped: The study was suspended and during this time recruitment and study activities were halted. The study was ultimately terminated in April 2026 without having re-opened for recruitment additional participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Fayfman, Emory University
- Investigators
- Maya Fayfman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416269
- Sponsor's protocol ID
- IRB00117027
- Other IDs
- 1K23DK124647-01, 2025P013073
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2020
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04416269
- Acronym / sponsor ID
- IRB00117027
- Conditions
- Diabetes Mellitus
- Keywords
- Hyperglycemia, Insulin therapy, Oral therapy, Basal bolus therapy, Mean daily blood glucose, Hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended and during this time recruitment and study activities were halted. The study was ultimately terminated in April 2026 without having re-opened for recruitment additional participants.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose (BG) concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Detailed description
Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Improving glycemic control has been shown to improve length of stay, multi-organ failure, systemic infections, as well as short- and long-term mortality. Clinical guidelines from professional organizations recommend the use of subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical and surgical patients with T2D. This approach, however, is labor intensive requiring multiple daily insulin injections, costly, and associated with significant risk of iatrogenic hypoglycemia
Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the lack of safety and efficacy data from randomized controlled trials, clinical guidelines recommend stopping OADs during hospitalization. The current clinical guidelines have raised concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid retention and worsening of heart failure with thiazolidinediones, and risk of metformin-associated lactic acidosis in patients with severe renal impairment. However, several observational studies have reported that the use of OADs results in similar glycemic control without increased risk of complications compared to insulin regimens. A recent observational study that included 17,325 hospitalized patients with T2D, found that patients treated with OADs had similar glycemic control without differences in complications and no increase in rates of hypoglycemia compared to those treated with insulin.
This study will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in hospital patients with T2D. For a subset of participants, a CGM device will be placed for the duration of the study to assess parameters of glycemic control and hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Anti-diabetes Drugs (OADs) alone | Experimental | Drug: Oral Anti-diabetes Drugs alone, Drug: Supplemental insulin, Device: Continuous glucose monitoring (CGM)OADs will be continued at same outpatient dosage unless contraindicated |
| Basal bolus insulin | Active comparator | Drug: Basal bolus insulin, Drug: Supplemental insulin, Device: Continuous glucose monitoring (CGM)Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females, age 18-80 years admitted to a general medicine and surgery services
- Known history of T2D receiving OADs either as monotherapy or in combination therapy
- Admission BG < 250 mg/dl or randomization BG <250 mg/dl and not receiving basal insulin
- Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c <7.5% within the past three months
- HbA1c <10%
Key exclusion criteria (12 listed)
- No known history of diabetes
- Laboratory evidence of diabetic ketoacidosis
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)
- Meeting any exclusion criteria based on specific contraindications to their home oral therapy
- Acute critical illness or cardiac surgery 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 |
|---|---|---|
| Oral Anti-diabetes Drugs aloneAlso: metformin, sulfonylureas, pioglitazone, dipeptidyl peptidase-4 (DPP-4) inhibitorsOADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment. | Drug | Oral Anti-diabetes Drugs (OADs) alone |
| Basal bolus insulinAlso: glargine, detemirBasal insulin with glargine or detemir will be used as per the hospital formulary. | Drug | Basal bolus insulin |
| Supplemental insulinAlso: Humalog, NovologSupplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG >140 mg/dl. | Drug | Basal bolus insulin, Oral Anti-diabetes Drugs (OADs) alone |
| Continuous glucose monitoring (CGM)Also: DexcomA subset of participants will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment. The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes. | Device | Basal bolus insulin, Oral Anti-diabetes Drugs (OADs) alone |
Primary outcome
Mean Daily Blood Glucose (BG) Concentration
Time frame: During hospital stay (up to 10 days)
Mean daily BG concentration is compared between OADs and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
24 secondary outcomes
Number of Mild Hypoglycemic Events
Time frame: During hospital stay (up to 10 days)
Number of Clinically Significant Hypoglycemic Events
Time frame: During hospital stay (up to 10 days)
Number of Severe Hypoglycemic Severe (<40 mg/dl) Events
Time frame: During hospital stay (up to 10 days)
Percent of Blood Glucose Values Within Target Range Without Hypoglycemia
Time frame: During hospital stay (up to 10 days)
Number of Episodes of Hyperglycemia After the First Day of Treatment
Time frame: During hospital stay (up to 10 days)
Units Per Day of Insulin
Time frame: During hospital stay (up to 10 days)
Number of Patients Using Specific Oral Antidiabetic Drugs (OADs) During Hospitalization
Time frame: During hospital stay (up to 10 days)
Number of Patients on OADs Requiring Insulin Rescue Therapy
Time frame: During hospital stay (up to 10 days)
Number of Episodes of Treatment Failure
Time frame: During hospital stay (up to 10 days)
Glycemic Variability in Participants Receiving CGM Monitoring
Time frame: During hospital stay (up to 10 days)
Percentage of Time Above BG Target Range (>180 mg/dl) in Participants Receiving CGM Monitoring
Time frame: During hospital stay (up to 10 days)
Percentage of Time in BG Target Range (70-180 mg/dl) in Participants Receiving CGM Monitoring
Time frame: During hospital stay (up to 10 days)
Percentage of Time Below BG Target Range (BG <70 mg/dl) in Participants Receiving CGM Monitoring
Time frame: During hospital stay (up to 10 days)
Number of Hospital Complications
Time frame: During hospital stay (up to 10 days)
In-hospital Mortality
Time frame: During hospital stay (up to 10 days)
Number of Individual Hospital Complications
Time frame: Up to 40 days (hospital stay plus 30 days after discharge)
Hospital Costs
Time frame: During hospital stay (up to 10 days)
Length of Hospital Stay
Time frame: During hospital stay (up to 10 days)
Costs for Diabetes Specific Therapies
Time frame: During hospital stay (up to 10 days)
Number of Hospital Re-admissions
Time frame: within 30 days of hospital discharge
Number of Emergency Room Visits
Time frame: within 30 days of hospital discharge
Number of Participants Requiring ICU Care
Time frame: During hospital stay (up to 10 days)
Nursing Antihyperglycemic Drug Preference Survey
Time frame: Day of hospital discharge (up to 10 days)
Patient Antihyperglycemic Drug Preference Survey
Time frame: Day of hospital discharge (up to 10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.
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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.
Maya Fayfman, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Anti-diabetes Drugs alone, Basal bolus insulin and Supplemental insulin in people with Diabetes Mellitus, run by Emory University at 3 sites in United States.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Daily Blood Glucose (BG) Concentration (time frame: During hospital stay (up to 10 days)). 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 31 Aug 2026.