Type 2 DiabetesPhase 4NCT01845831
Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
A Phase 4 study testing Sitagliptin, Basal Bolus and Metformin and Sitagliptin in people with Type 2 Diabetes, run by Emory University at 5 sites in United States.
Trial summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin, Basal Bolus and Metformin and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2013to Apr 2016
- 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 between the ages of 18 and 80 years admitted to medicine and surgery services.
- A known history of Type 2 Diabetes > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.6 units/kg/day) insulin therapy.
- Subjects with a blood glucose >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Who cannot join
- Age < 18 or > 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) [46].
- Treatment with DPP4 inhibitor or Glucagon like peptide 1 (GLP1) analogs during the past 3 months prior to admission.
- Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
- Subjects with gastrointestinal obstruction or adynamic ileus or those 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.
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
- Treatment with oral or injectable corticosteroid = or > prednisone 5 mg/per day.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30324
Ohio State University
Columbus, Ohio, 43210
Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: Randomized Controlled Trial on the Safety and Efficacy of Sitagliptin Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot study aiming to determine differences in glycemic control between treatment with sitagliptin (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general medicine and surgery patients with type 2 diabetes (T2D). The investigators found that treatment with sitagliptin alone or in combination with basal insulin resulted in similar glycemic control compared to basal bolus regimen.
The investigators will conduct a prospective RCT aimed to determine the safety and efficacy of sitagliptin therapy for in-hospital and post-discharge management of general medicine and surgical patients with T2D. A total of 280 patients with known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group 2). If needed, patients in the treatment groups will receive correction doses of rapid-acting insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall hypothesis is that treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in hospital and post-discharge glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals.
Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University of Michigan, Ohio State University and Temple University
Read the detailed description
Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily blood glucose concentration and frequency of hypoglycemic events, is different between treatment with sitagliptin (Januvia®) in combination with basal insulin (glargine) and basal bolus regimen (glargine and rapid-acting insulin analog) in general medicine and surgery patients with T2D. Patients with T2D treated with diet and/or OAD or with low total daily dose insulin therapy (≤0.6 unit/kg/day) will be randomized to receive sitagliptin plus glargine insulin (group 1) or basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals (group 2). If needed, patients in the 2 treatment groups will receive supplemental (correction) doses of rapid-acting insulin before meals for BG > 140 mg/dl.
Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital (Aim 1) arm will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 6 months. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ®) twice daily. Those with HbA1c between 7% and 9% will be discharged on metformin and sitagliptin (Janumet ®) twice daily plus glargine insulin at 50% of the inpatient glargine dose. Those with HbA1c > 9% will be discharged on metformin and sitagliptin (Janumet ®) twice-daily plus glargine insulin at 80% of the inpatient dose.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin, Basal Bolus, Metformin and Sitagliptin, Glargine, Glargine 50%
- Keywords
- Diabetes, DPP4 inhibitors, Sitagliptin, Glargine, RCT, basal insulin, hospital hyperglycemia, inpatient diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin will be taken orally at 100 mg or 50 mg once a day per renal function.
Basal BolusDrug
Also called Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)
Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
Metformin and SitagliptinDrug
Also called Janumet
Janumet is a combination of metformin and sitagliptin. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months.
GlargineDrug
Also called Lantus
Patients with blood glucose between 140-200 mg/dL during hospitalization will receive 0.2 units per kg weight per day.
Patients with blood glucose between 201-400 mg/dL during hospitalization will receive 0.25 units per kg weight per day.
Glargine 50%Drug
Glargine will be prescribed at 50% of daily hospital dose.
Glargine 80%Drug
Glargine will be prescribed at 80% of daily hospital dose.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin + glargine (Hospital) | Experimental | Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed Receives: Drug: Sitagliptin; Drug: Glargine |
| Basal bolus (Hospital) | Active comparator | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Receives: Drug: Basal Bolus |
| Metformin and Sitagliptin | Experimental | Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months Receives: Drug: Metformin and Sitagliptin |
| Metformin and sitagliptin + glargine 50% | Experimental | Patients with HbA1c between 7% and 9% will be discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months Receives: Drug: Metformin and Sitagliptin; Drug: Glargine 50% |
| Metformin and sitagliptin + glargine 80% | Experimental | Patients with HbA1c > 9% will be discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months Receives: Drug: Metformin and Sitagliptin; Drug: Glargine 80% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Blood Glucose Concentration After First Day of Treatment
The average blood glucose (BG) concentration after the first day of treatment
Measured: Duration of Hospitalization (Up to 10 Days)
Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Measured: Duration of Hospitalization (Up to 10 Days)
Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Measured: Duration of Hospitalization (Up to 10 Days)
Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Measured: Duration of Hospitalization (Up to 10 Days)
Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Measured: Duration of Hospitalization (Up to 10 Days)
Change in HbA1C
The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.
Measured: Post Hospital Discharge Month 3, Month 6
Secondary outcomes (5)
Number of Participants With a Hypoglycemic Event
The number of participants who had a hypoglycemic event during hospitalization.
Measured: Duration of Hospitalization (Up to 10 Days)
Total Daily Insulin Dose
Daily insulin requirement (units per day).
Measured: Duration of Hospitalization (Up to 10 Days)
Length of Hospital Stay
Length of hospital stay in days.
Measured: Duration of Hospitalization (Up to 10 Days)
Acute Renal Failure Rate
Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment > 0.5 mg/dL from baseline).
Measured: Duration of Hospitalization (Up to 10 Days)
Hospital Mortality Rate
Mortality is defined as death occurring during admission.
Measured: Duration of 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 posted3 May 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2016
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Temple University, University of Michigan, Ohio University
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845831
- Sponsor's protocol ID
- IRB00063642
- Status last verified
- Apr 2017
- First submitted
- 30 Apr 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pasquel 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 27964837
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Safety and Efficacy of Sitagliptin Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01845831
- Acronym / sponsor ID
- IRB00063642
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, DPP4 inhibitors, Sitagliptin, Glargine, RCT, basal insulin, hospital hyperglycemia, inpatient diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Temple University, University of Michigan, Ohio University
- Study start
- Aug 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Posted 30 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot study aiming to determine differences in glycemic control between treatment with sitagliptin (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general medicine and surgery patients with type 2 diabetes (T2D). The investigators found that treatment with sitagliptin alone or in combination with basal insulin resulted in similar glycemic control compared to basal bolus regimen.
The investigators will conduct a prospective RCT aimed to determine the safety and efficacy of sitagliptin therapy for in-hospital and post-discharge management of general medicine and surgical patients with T2D. A total of 280 patients with known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group 2). If needed, patients in the treatment groups will receive correction doses of rapid-acting insulin in the presence of hyperglycemia (BG > 140 mg/dl). The overall hypothesis is that treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in hospital and post-discharge glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals.
Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University of Michigan, Ohio State University and Temple University
Detailed description
Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily blood glucose concentration and frequency of hypoglycemic events, is different between treatment with sitagliptin (Januvia®) in combination with basal insulin (glargine) and basal bolus regimen (glargine and rapid-acting insulin analog) in general medicine and surgery patients with T2D. Patients with T2D treated with diet and/or OAD or with low total daily dose insulin therapy (≤0.6 unit/kg/day) will be randomized to receive sitagliptin plus glargine insulin (group 1) or basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals (group 2). If needed, patients in the 2 treatment groups will receive supplemental (correction) doses of rapid-acting insulin before meals for BG > 140 mg/dl.
Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital (Aim 1) arm will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 6 months. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ®) twice daily. Those with HbA1c between 7% and 9% will be discharged on metformin and sitagliptin (Janumet ®) twice daily plus glargine insulin at 50% of the inpatient glargine dose. Those with HbA1c > 9% will be discharged on metformin and sitagliptin (Janumet ®) twice-daily plus glargine insulin at 80% of the inpatient dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin + glargine (Hospital) | Experimental | Drug: Sitagliptin, Drug: GlargineSitagliptin and glargine once daily + correction doses of aspart or lispro if needed |
| Basal bolus (Hospital) | Active comparator | Drug: Basal BolusGlargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed |
| Metformin and Sitagliptin | Experimental | Drug: Metformin and SitagliptinPatients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months |
| Metformin and sitagliptin + glargine 50% | Experimental | Drug: Metformin and Sitagliptin, Drug: Glargine 50%Patients with HbA1c between 7% and 9% will be discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months |
| Metformin and sitagliptin + glargine 80% | Experimental | Drug: Metformin and Sitagliptin, Drug: Glargine 80%Patients with HbA1c > 9% will be discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females between the ages of 18 and 80 years admitted to medicine and surgery services.
- A known history of Type 2 Diabetes > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.6 units/kg/day) insulin therapy.
- Subjects with a blood glucose >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
Key exclusion criteria (12 listed)
- Age < 18 or > 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) [46].
- Treatment with DPP4 inhibitor or Glucagon like peptide 1 (GLP1) analogs during the past 3 months prior to admission.
- Acute critical illness or coronary artery bypass graft (CABG) 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 |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin will be taken orally at 100 mg or 50 mg once a day per renal function. | Drug | Sitagliptin + glargine (Hospital) |
| Basal BolusAlso: Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | Drug | Basal bolus (Hospital) |
| Metformin and SitagliptinAlso: JanumetJanumet is a combination of metformin and sitagliptin. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months. | Drug | Metformin and Sitagliptin, Metformin and sitagliptin + glargine 50%, Metformin and sitagliptin + glargine 80% |
| GlargineAlso: LantusPatients with blood glucose between 140-200 mg/dL during hospitalization will receive 0.2 units per kg weight per day. Patients with blood glucose between 201-400 mg/dL during hospitalization will receive 0.25 units per kg weight per day. | Drug | Sitagliptin + glargine (Hospital) |
| Glargine 50%Glargine will be prescribed at 50% of daily hospital dose. | Drug | Metformin and sitagliptin + glargine 50% |
| Glargine 80%Glargine will be prescribed at 80% of daily hospital dose. | Drug | Metformin and sitagliptin + glargine 80% |
Primary outcome
Mean Blood Glucose Concentration After First Day of Treatment
Time frame: Duration of Hospitalization (Up to 10 Days)
The average blood glucose (BG) concentration after the first day of treatment
Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L
Time frame: Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L
Time frame: Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L
Time frame: Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L
Time frame: Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.
Change in HbA1C
Time frame: Post Hospital Discharge Month 3, Month 6
The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.
5 secondary outcomes
Number of Participants With a Hypoglycemic Event
Time frame: Duration of Hospitalization (Up to 10 Days)
Total Daily Insulin Dose
Time frame: Duration of Hospitalization (Up to 10 Days)
Length of Hospital Stay
Time frame: Duration of Hospitalization (Up to 10 Days)
Acute Renal Failure Rate
Time frame: Duration of Hospitalization (Up to 10 Days)
Hospital Mortality Rate
Time frame: Duration of Hospitalization (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 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
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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.
Guillermo Umpierrez, MD principal investigator
Emory University SOM
5 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 Sitagliptin, Basal Bolus and Metformin and Sitagliptin in people with Type 2 Diabetes, run by Emory University at 5 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 3 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: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 May 2017). 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 Blood Glucose Concentration After First Day of Treatment (time frame: Duration of Hospitalization (Up to 10 Days)). The study lists 6 primary outcomes in all. 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 NCT01845831, which also lists 1 linked publication.
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 30 May 2017.