Trial Outcomes & Findings for Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes (NCT NCT01845831)
NCT ID: NCT01845831
Last Updated: 2017-05-30
Results Overview
The average blood glucose (BG) concentration after the first day of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
292 participants
Primary outcome timeframe
Duration of Hospitalization (Up to 10 Days)
Results posted on
2017-05-30
Participant Flow
Participants were recruited between August 23, 2013 and July 27, 2015.
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|
|
Inpatient Phase
STARTED
|
140
|
139
|
0
|
0
|
0
|
|
Inpatient Phase
COMPLETED
|
139
|
138
|
0
|
0
|
0
|
|
Inpatient Phase
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
|
Outpatient Phase
STARTED
|
0
|
0
|
68
|
98
|
87
|
|
Outpatient Phase
COMPLETED
|
0
|
0
|
68
|
98
|
87
|
|
Outpatient Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|---|
|
Inpatient Phase
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Race/Ethnicity data were missing for three participants in the Basal/bolus group.
Baseline characteristics by cohort
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 11.4 • n=138 Participants
|
57.1 years
STANDARD_DEVIATION 10.4 • n=139 Participants
|
56.9 years
STANDARD_DEVIATION 10.9 • n=277 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=138 Participants
|
52 Participants
n=139 Participants
|
111 Participants
n=277 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=138 Participants
|
87 Participants
n=139 Participants
|
166 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=138 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
44 Participants
n=136 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
89 Participants
n=274 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
|
Race/Ethnicity, Customized
Black
|
81 Participants
n=138 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
78 Participants
n=136 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
159 Participants
n=274 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=138 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
14 Participants
n=136 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
26 Participants
n=274 Participants • Race/Ethnicity data were missing for three participants in the Basal/bolus group.
|
PRIMARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)The average blood glucose (BG) concentration after the first day of treatment
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Mean Blood Glucose Concentration After First Day of Treatment
|
9.5 mmol/L
Standard Deviation 2.7
|
9.4 mmol/L
Standard Deviation 2.7
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L
|
30.7 percentage of blood glucose readings
Standard Deviation 28.0
|
29.7 percentage of blood glucose readings
Standard Deviation 24.4
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L
|
57.0 percentage of blood glucose readings
Standard Deviation 31.5
|
59.6 percentage of blood glucose readings
Standard Deviation 30.1
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L
|
23.3 percentage of blood glucose readings
Standard Deviation 21.8
|
23.5 percentage of blood glucose readings
Standard Deviation 19.9
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L
|
14.8 percentage of blood glucose readings
Standard Deviation 22.1
|
16.7 percentage of blood glucose readings
Standard Deviation 24.1
|
—
|
PRIMARY outcome
Timeframe: Post Hospital Discharge Month 3, Month 6Population: 253 subjects who participated in the inpatient phase and were invited to complete the outpatient phase.
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.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=68 Participants
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)
n=98 Participants
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 + Glargine 80%
n=87 Participants
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
|
|---|---|---|---|
|
Change in HbA1C
Baseline
|
6.3 percent
Standard Deviation .5
|
8.0 percent
Standard Deviation 0.6
|
11.3 percent
Standard Deviation 1.7
|
|
Change in HbA1C
Month 3
|
6.3 percent
Standard Deviation .8
|
7.3 percent
Standard Deviation 1.1
|
8.0 percent
Standard Deviation 1.8
|
|
Change in HbA1C
Month 6
|
6.2 percent
Standard Deviation 1.0
|
7.3 percent
Standard Deviation 1.3
|
8.0 percent
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)The number of participants who had a hypoglycemic event during hospitalization.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Number of Participants With a Hypoglycemic Event
Blood Glucose <3.9 mmol/L
|
13 Participants
|
17 Participants
|
—
|
|
Number of Participants With a Hypoglycemic Event
Blood Glucose <2.2 mmol/L
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)Daily insulin requirement (units per day).
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Total Daily Insulin Dose
|
24.1 units per day
Standard Error 16.2
|
34.0 units per day
Standard Error 20.1
|
—
|
SECONDARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)Length of hospital stay in days.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Length of Hospital Stay
|
4.0 days
Interval 3.0 to 8.0
|
4.0 days
Interval 3.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)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).
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Acute Renal Failure Rate
|
7 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: Duration of Hospitalization (Up to 10 Days)Mortality is defined as death occurring during admission.
Outcome measures
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 Participants
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)
n=139 Participants
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 + 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
|
|---|---|---|---|
|
Hospital Mortality Rate
|
0 participants
|
0 participants
|
—
|
Adverse Events
Sitagliptin + Glargine (Hospital)
Serious events: 10 serious events
Other events: 2 other events
Deaths: 0 deaths
Basal Bolus (Hospital)
Serious events: 9 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 participants at risk
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)
n=139 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.4%
2/138 • Number of events 2 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
0.72%
1/139 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
|
Injury, poisoning and procedural complications
Acute Kidney Injury
|
5.1%
7/138 • Number of events 7 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
4.3%
6/139 • Number of events 6 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
|
Surgical and medical procedures
Reoperation
|
0.72%
1/138 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
0.72%
1/139 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/138 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
0.72%
1/139 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
Other adverse events
| Measure |
Sitagliptin + Glargine (Hospital)
n=138 participants at risk
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)
n=139 participants at risk
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
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|---|---|---|
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Infections and infestations
Wound Infection
|
0.00%
0/138 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
0.72%
1/139 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.4%
2/138 • Number of events 2 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
|
0.72%
1/139 • Number of events 1 • Adverse events were collected throughout the duration of the study (2 years) including the inpatient and outpatient phases.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place