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Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sitagliptin

Basal Bolus

Metformin and Sitagliptin

Glargine

Glargine 50%

Glargine 80%

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, DPP4 inhibitors, Sitagliptin, Glargine, RCT, basal insulin, hospital hyperglycemia, inpatient diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.
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.

Sites / Locations

Grady Memorial Hospital
Emory University Hospital
University of Michigan
Ohio State University
Temple University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Sitagliptin + glargine (Hospital)

Basal bolus (Hospital)

Metformin and Sitagliptin

Metformin and sitagliptin + glargine 50%

Metformin and sitagliptin + glargine 80%

Arm Description

Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed

Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed

Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months

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

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

Outcomes

Primary Outcome Measures

Mean Blood Glucose Concentration After First Day of Treatment

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

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

Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L

Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L

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.

Secondary Outcome Measures

Number of Participants With a Hypoglycemic Event

The number of participants who had a hypoglycemic event during hospitalization.

Total Daily Insulin Dose

Daily insulin requirement (units per day).

Length of Hospital Stay

Length of hospital stay in 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).

Hospital Mortality Rate

Mortality is defined as death occurring during admission.

Full Information

NCT ID

NCT01845831

First Posted

April 30, 2013

Last Updated

April 24, 2017

Sponsor

Emory University

Collaborators

Merck Sharp & Dohme LLC, Temple University, University of Michigan, Ohio University

1. Study Identification

Unique Protocol Identification Number

NCT01845831

Brief Title

Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Merck Sharp & Dohme LLC, Temple University, University of Michigan, Ohio University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Diabetes, DPP4 inhibitors, Sitagliptin, Glargine, RCT, basal insulin, hospital hyperglycemia, inpatient diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin + glargine (Hospital)

Arm Type

Experimental

Arm Description

Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed

Arm Title

Basal bolus (Hospital)

Arm Type

Active Comparator

Arm Description

Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed

Arm Title

Metformin and Sitagliptin

Arm Type

Experimental

Arm Description

Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months

Arm Title

Metformin and sitagliptin + glargine 50%

Arm Type

Experimental

Arm Description

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

Arm Title

Metformin and sitagliptin + glargine 80%

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

Januvia

Intervention Description

Sitagliptin will be taken orally at 100 mg or 50 mg once a day per renal function.

Intervention Type

Drug

Intervention Name(s)

Basal Bolus

Other Intervention Name(s)

Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)

Intervention Description

Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed

Intervention Type

Drug

Intervention Name(s)

Metformin and Sitagliptin

Other Intervention Name(s)

Janumet

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Glargine

Other Intervention Name(s)

Lantus

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Glargine 50%

Intervention Description

Glargine will be prescribed at 50% of daily hospital dose.

Intervention Type

Drug

Intervention Name(s)

Glargine 80%

Intervention Description

Glargine will be prescribed at 80% of daily hospital dose.

Primary Outcome Measure Information:

Title

Mean Blood Glucose Concentration After First Day of Treatment

Description

The average blood glucose (BG) concentration after the first day of treatment

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L

Description

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L

Description

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L

Description

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L

Description

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Change in HbA1C

Description

Time Frame

Post Hospital Discharge Month 3, Month 6

Secondary Outcome Measure Information:

Title

Number of Participants With a Hypoglycemic Event

Description

The number of participants who had a hypoglycemic event during hospitalization.

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Total Daily Insulin Dose

Description

Daily insulin requirement (units per day).

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Length of Hospital Stay

Description

Length of hospital stay in days.

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Acute Renal Failure Rate

Description

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).

Time Frame

Duration of Hospitalization (Up to 10 Days)

Title

Hospital Mortality Rate

Description

Mortality is defined as death occurring during admission.

Time Frame

Duration of Hospitalization (Up to 10 Days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillermo Umpierrez, MD

Organizational Affiliation

Emory University SOM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grady Memorial Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30324

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27964837

Citation

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. Erratum In: Lancet Diabetes Endocrinol. 2017 Feb;5(2):e1. Lancet Diabetes Endocrinol. 2017 May;5(5):e3.

Results Reference

derived

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Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

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