Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02408120
• Collaborator: (none)
• Enrollment: 226
• Locations: 2
• Arms: 2
• Duration (Months): 50.3
• Patients Per Site: 113
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glargine; Drug: Insulin aspart; Drug: Supplemental insulin aspart	Phase 4

Detailed Description

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.

Study Design

• Study Type: Interventional
• Actual Enrollment: 226 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes Treated With Basal Bolus Insulin Regimen
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 11, 2019
• Actual Study Completion Date: Dec 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Insulin Aspart for BG > 140 mg/dL Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Drug: Insulin glargine; Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day. Daily insulin dose will be adjusted as follow: If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Other Names: Lantus (glargine) ; Drug: Insulin aspart; Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held. Daily insulin dose will be adjusted as follow: If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Other Names: Novolog ; Drug: Supplemental insulin aspart; Insulin aspart will be administered following the supplemental insulin scale protocol. For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows: BG >141-180 mg/dL; 2-4 units of insulin aspart BG between 181-220 mg/dL; 3-6 units of insulin aspart BG between 221-260 mg/dL; 4-8 units of insulin aspart BG between 261-300 mg/dL; 5-10 units of insulin aspart BG between 301-350 mg/dL; 6-12 units of insulin aspart BG between 351-400 mg/dL; 7-14 units of insulin aspart BG > 400 mg/dL; 8-16 units of insulin aspart For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows: BG between 261-300 mg/dL; 5-10 units of insulin aspart BG between 301-350 mg/dL; 6-12 units of insulin aspart BG between 351-400 mg/dL; 7-14 units of insulin aspart BG > 400 mg/dL; 8-16 units of insulin aspart; Other Names: Novolog
Active Comparator: Insulin Aspart for BG > 260 mg/dL Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.	Drug: Insulin glargine; Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day. Daily insulin dose will be adjusted as follow: If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Other Names: Lantus (glargine) ; Drug: Insulin aspart; Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held. Daily insulin dose will be adjusted as follow: If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%.; Other Names: Novolog ; Drug: Supplemental insulin aspart; Insulin aspart will be administered following the supplemental insulin scale protocol. For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows: BG >141-180 mg/dL; 2-4 units of insulin aspart BG between 181-220 mg/dL; 3-6 units of insulin aspart BG between 221-260 mg/dL; 4-8 units of insulin aspart BG between 261-300 mg/dL; 5-10 units of insulin aspart BG between 301-350 mg/dL; 6-12 units of insulin aspart BG between 351-400 mg/dL; 7-14 units of insulin aspart BG > 400 mg/dL; 8-16 units of insulin aspart For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows: BG between 261-300 mg/dL; 5-10 units of insulin aspart BG between 301-350 mg/dL; 6-12 units of insulin aspart BG between 351-400 mg/dL; 7-14 units of insulin aspart BG > 400 mg/dL; 8-16 units of insulin aspart; Other Names: Novolog

Outcome Measures

Primary Outcome Measures

1. Mean Daily BG Levels [5 days (average time of discharge from the hospital)]

   Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.

Secondary Outcome Measures

1. Mean Blood Glucose Levels Before Lunch [5 days (average time of discharge from the hospital)]

   The blood glucose levels will be assessed prior to lunch using a glucose meter.

2. Mean Blood Glucose Levels at Bedtime [5 days (average time of discharge from the hospital)]

   The blood glucose levels will be assessed at bedtime using a glucose meter.

3. Mean Blood Glucose Levels Before Dinner [5 days (average time of discharge from the hospital)]

   The blood glucose levels will be assessed before dinner using a glucose meter.

4. Incidence of Hypoglycemia [5 days (average time of discharge from the hospital)]

   The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.

5. Incidence of Hyperglycemia [5 days (average time of discharge from the hospital)]

   The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded.

6. Number of Blood Glucose Readings Within 100-140 mg/dL Range [5 days (average time of discharge from the hospital)]

   The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.

7. Average Number of Days of Hospital Stay [5 days (average time of discharge from the hospital)]

   The average number of days in the hospital for subjects will be calculated.

8. Mortality [5 days (average time of discharge from the hospital)]

   The total number of subject deaths during hospital stay will be recorded.

9. Number of Subjects That Experienced Hospital Complications [5 days (average time of discharge from the hospital)]

   The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.

10. Mean Daily Dose of Insulin [5 days (average time of discharge from the hospital)]

    Daily dose of insulin will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma

2. Known history of Type 2 diabetes mellitus for >3 months

3. Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy

4. Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis

Exclusion Criteria:

1. Hyperglycemia without a history of diabetes

2. Subjects with acute critical illness admitted to the ICU or expected to require ICU admission

3. Subjects receiving continuous insulin infusion

4. Clinically relevant hepatic disease

5. Corticosteroid therapy

6. Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30

7. Subjects unable to sign consent

8. Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grady Memorial Hospital	Atlanta	Georgia	United States	30303
2	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Priyathama Vellanki, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 14, 2017

More Information

Publications

None provided.

• Responsible Party: Priyathama Vellanki, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02408120
• Other Study ID Numbers: IRB00078695
• First Posted: Apr 3, 2015
• Last Update Posted: Jan 6, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Priyathama Vellanki, Assistant Professor, Emory University: Hyperglycemia; Hypoglycemia
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination

Study Results

Participant Flow

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Period Title: Overall Study
STARTED	112	112
COMPLETED	108	107
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL	Total
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.	Total of all reporting groups
Overall Participants	108	107	215
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	76 70.4%	78 72.9%	154 71.6%
>=65 years	32 29.6%	29 27.1%	61 28.4%
Sex: Female, Male (Count of Participants)
Female	57 52.8%	58 54.2%	115 53.5%
Male	51 47.2%	49 45.8%	100 46.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	92 85.2%	82 76.6%	174 80.9%
White	15 13.9%	22 20.6%	37 17.2%
More than one race	1 0.9%	3 2.8%	4 1.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	108 100%	107 100%	215 100%

Outcome Measures

1. Primary Outcome

Title	Mean Daily BG Levels
Description	Blood glucose (BG) will be measured, and mean daily BG levels will be calculated.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Mean (Standard Deviation) [mg/dL]	172 (38.2)	173 (43)

2. Secondary Outcome

Title	Mean Blood Glucose Levels Before Lunch
Description	The blood glucose levels will be assessed prior to lunch using a glucose meter.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Mean (Standard Deviation) [mg/dL]	160 (16)	172 (14)

3. Secondary Outcome

Title	Mean Blood Glucose Levels at Bedtime
Description	The blood glucose levels will be assessed at bedtime using a glucose meter.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Mean (Standard Deviation) [mg/dl]	157 (18)	171 (9)

4. Secondary Outcome

Title	Mean Blood Glucose Levels Before Dinner
Description	The blood glucose levels will be assessed before dinner using a glucose meter.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Mean (Standard Deviation) [mg/dL]	151 (19)	160 (10)

5. Secondary Outcome

Title	Incidence of Hypoglycemia
Description	The number of occurrences of hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Number [number of events]	16	15

6. Secondary Outcome

Title	Incidence of Hyperglycemia
Description	The number of occurrences of hyperglycemia (blood glucose levels > 260 mg/dL) will be recorded.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Number [number of events]	45	42

7. Secondary Outcome

Title	Number of Blood Glucose Readings Within 100-140 mg/dL Range
Description	The number of blood glucose readings that are in the target range of 100-140 mg/dL will be recorded.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Number [number of readings]	59	57

8. Secondary Outcome

Title	Average Number of Days of Hospital Stay
Description	The average number of days in the hospital for subjects will be calculated.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Median (Inter-Quartile Range) [days]	4	4

9. Secondary Outcome

Title	Mortality
Description	The total number of subject deaths during hospital stay will be recorded.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Count of Participants [Participants]	1 0.9%	0 0%

10. Secondary Outcome

Title	Number of Subjects That Experienced Hospital Complications
Description	The total number of subjects in which hospital complications occurred prior to discharge will be recorded. These complications will mainly be cases of nosocomial infections, pneumonia, bacteremia, respiratory failure, and acute kidney injury [rise of serum creatinine >0.5 mg/dL (or 50%) of baseline value]. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Count of Participants [Participants]	11 10.2%	12 11.2%

11. Secondary Outcome

Title	Mean Daily Dose of Insulin
Description	Daily dose of insulin will be recorded
Time Frame	5 days (average time of discharge from the hospital)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Insulin Aspart for BG > 140 mg/dL	Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
Measure Participants	108	107
Mean (Standard Deviation) [units/day]	47 (43)	41 (30)

Adverse Events

Time Frame	1 week
Arm/Group Title	Insulin Aspart for BG > 140 mg/dL		Insulin Aspart for BG > 260 mg/dL
Arm/Group Description	Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >140 mg/dL.		Subjects will consist of hospitalized patients with type 2 diabetes and be randomized to receive insulin glargine once daily and insulin aspart divided in three equal doses before meals. Supplemental insulin aspart will be given before meals and at bedtime to subjects with blood glucose (BG) levels >260 mg/dL.
All Cause Mortality
	Insulin Aspart for BG > 140 mg/dL		Insulin Aspart for BG > 260 mg/dL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/108 (0.9%)		0/107 (0%)
Serious Adverse Events
	Insulin Aspart for BG > 140 mg/dL		Insulin Aspart for BG > 260 mg/dL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/108 (0%)		0/107 (0%)
Other (Not Including Serious) Adverse Events
	Insulin Aspart for BG > 140 mg/dL		Insulin Aspart for BG > 260 mg/dL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/108 (10.2%)		12/107 (11.2%)
Infections and infestations
Infection	0/108 (0%)		1/107 (0.9%)
Renal and urinary disorders
Acute Kidney Injury	10/108 (9.3%)		11/107 (10.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/108 (0.9%)		0/107 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.