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Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01845831
First Posted: May 3, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Temple University
University of Michigan
Ohio University
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
Results First Submitted: March 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Sitagliptin
Drug: Basal Bolus
Drug: Metformin and Sitagliptin
Drug: Glargine
Drug: Glargine 50%
Drug: Glargine 80%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between August 23, 2013 and July 27, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 292 subjects who consented for participation, 279 began the inpatient study phase. Two hundred and fifty-three participants began the outpatient study phase.

Reporting Groups
  Description
Sitagliptin + Glargine (Hospital)

Inpatient Phase:

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

Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed

Basal Bolus (Hospital)

Inpatient Phase:

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

Basal Bolus: 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 Sitagliptin

Outpatient Phase:

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

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

Metformin and Sitagliptin + Glargine 50%

Outpatient Phase:

Patients with HbA1c between 7% and 9% during the inpatient phase were 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 50%: Patients with HbA1c between 7% and 9% were 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%

Outpatient Phase:

Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months

Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months


Participant Flow for 2 periods

Period 1:   Inpatient Phase
    Sitagliptin + Glargine (Hospital)   Basal Bolus (Hospital)   Metformin and Sitagliptin   Metformin and Sitagliptin + Glargine 50%   Metformin and Sitagliptin + Glargine 80%
STARTED   140   139   0   0   0 
COMPLETED   139   138   0   0   0 
NOT COMPLETED   1   1   0   0   0 
Withdrawal by Subject                1                1                0                0                0 

Period 2:   Outpatient Phase
    Sitagliptin + Glargine (Hospital)   Basal Bolus (Hospital)   Metformin and Sitagliptin   Metformin and Sitagliptin + Glargine 50%   Metformin and Sitagliptin + Glargine 80%
STARTED   0   0   68   98   87 
COMPLETED   0   0   68   98   87 
NOT COMPLETED   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The number of participants who received at least one dose of study drug.

Reporting Groups
  Description
Sitagliptin + Glargine (Hospital)

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

Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed

Basal Bolus (Hospital)

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

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

Total Total of all reporting groups

Baseline Measures
   Sitagliptin + Glargine (Hospital)   Basal Bolus (Hospital)   Total 
Overall Participants Analyzed 
[Units: Participants]
 138   139   277 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 138   139   277 
   56.8  (11.4)   57.1  (10.4)   56.9  (10.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 138   139   277 
Female      59  42.8%      52  37.4%      111  40.1% 
Male      79  57.2%      87  62.6%      166  59.9% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
     
White       
Participants Analyzed 
[Units: Participants]
 138   136   274 
White   45   44   89 
Black       
Participants Analyzed 
[Units: Participants]
 138   136   274 
Black   81   78   159 
Other       
Participants Analyzed 
[Units: Participants]
 138   136   274 
Other   12   14   26 
[1] Race/Ethnicity data were missing for three participants in the Basal/bolus group.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Blood Glucose Concentration After First Day of Treatment   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

2.  Primary:   Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

3.  Primary:   Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

4.  Primary:   Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

5.  Primary:   Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

6.  Primary:   Change in HbA1C   [ Time Frame: Post Hospital Discharge Month 3, Month 6 ]

7.  Secondary:   Number of Participants With a Hypoglycemic Event   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

8.  Secondary:   Total Daily Insulin Dose   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

9.  Secondary:   Length of Hospital Stay   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

10.  Secondary:   Acute Renal Failure Rate   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]

11.  Secondary:   Hospital Mortality Rate   [ Time Frame: Duration of Hospitalization (Up to 10 Days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As a single DPP-4 inhibitor, sitagliptin, was used, results cannot be generalized to other incretin-based drugs. Additionally, the proportion of surgical patients was small, and the results may not be generalized to all surgical patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT01845831     History of Changes
Other Study ID Numbers: IRB00063642
First Submitted: April 30, 2013
First Posted: May 3, 2013
Results First Submitted: March 8, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017