Trial Outcomes & Findings for Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM (NCT NCT01855243)

NCT ID: NCT01855243

Last Updated: 2019-01-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: during hospital stay which is expected to be average 3 weeks
• Results posted on: 2019-01-15

Participant Flow

a known history of type 2 DM for longer than 3 months admitted to general medicine wards, age between 18 - 64 year old, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.

Participant milestones

Measure	Glargine Plus Supplemental Glulisine Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Overall Study STARTED	20	21	22
Overall Study COMPLETED	19	21	22
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Glargine Plus Supplemental Glulisine Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Overall Study develpoed diabetic ketoacidosis	1	0	0

Baseline Characteristics

Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Baseline characteristics by cohort

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin	Total n=62 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants	55 years STANDARD_DEVIATION 7 • n=7 Participants	55 years STANDARD_DEVIATION 7 • n=5 Participants	55 years STANDARD_DEVIATION 9 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Region of Enrollment Egypt	19 participants n=5 Participants	21 participants n=7 Participants	22 participants n=5 Participants	62 participants n=4 Participants
Body weight	75 Kg STANDARD_DEVIATION 11 • n=5 Participants	78 Kg STANDARD_DEVIATION 20 • n=7 Participants	73 Kg STANDARD_DEVIATION 12 • n=5 Participants	76 Kg STANDARD_DEVIATION 15 • n=4 Participants
BMI	31 Kg/m2 STANDARD_DEVIATION 6 • n=5 Participants	31 Kg/m2 STANDARD_DEVIATION 7 • n=7 Participants	31 Kg/m2 STANDARD_DEVIATION 5 • n=5 Participants	31 Kg/m2 STANDARD_DEVIATION 5 • n=4 Participants

PRIMARY outcome

Timeframe: during hospital stay which is expected to be average 3 weeks

Outcome measures

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.	221 mg/dL Standard Deviation 67	179 mg/dL Standard Deviation 36	222 mg/dL Standard Deviation 67

PRIMARY outcome

Timeframe: after first day of hospitalization

Outcome measures

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Mean BG After First Day of Hospitalization	225 mg/dL Standard Deviation 65	171 mg/dL Standard Deviation 38	218 mg/dL Standard Deviation 71

SECONDARY outcome

Timeframe: during hospital stay which is expected to be average 3 weeks

Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events.

Outcome measures

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Number of Patients Developed Hypoglycemic Events Minor (BG between 40 - 59 mg/dL	3 participants	0 participants	1 participants
Number of Patients Developed Hypoglycemic Events Major (BG ≤ 40 mg/dL)	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: during hospital stay which is expected to be average 3 weeks

Hyperglycemic events are defined as BG > 300 mg/dL.

Outcome measures

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Number of Patients Developed Episodes of Severe Hyperglycemia	10 participants	4 participants	15 participants

SECONDARY outcome

Timeframe: during the hospital stay which is expected to be average 3 weeks

Outcome measures

Measure	Glargine Plus Supplemental Glulisine n=19 Participants Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 Participants Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=22 Participants For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Mortality Rate	0 participants	0 participants	0 participants

Adverse Events

Glargine Plus Supplemental Glulisine

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

70/30 Insulin Plus Supplemental Lunch Insulin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sliding Scale Insulin (SSI)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Glargine Plus Supplemental Glulisine n=19 participants at risk Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 participants at risk Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=21 participants at risk；n=22 participants at risk For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Nervous system disorders major hypoglycemia	10.5% 2/19 • Number of events 3 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness	0.00% 0/21 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness	0.00% 0/22 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness

Other adverse events

Measure	Glargine Plus Supplemental Glulisine n=19 participants at risk Patients who will be recruited to be treated with glargine/glulisine, will received 50% of TDD as detailed demonstrated in Umpierrez et al., studies . as This includes administration of glargine (Lantus®) once every night plus glulisine (Apidra®) before each meal for BG ≥ 150 mg/dL. Glargine dose will be calculated as 0.2 U/kg/day for admission BG less than 200 mg/dL or 0.3 U/kg/day for BG exceeding 200 mg/dL. Glargine was given using Solostar Flex-Pen® once daily in the evening around 8:00 pm. Glulisine was given using the Solostar Flex-Pen® three times just before the meals for BG \> 150 mg/dL according to hospital sliding scale. To avoid hypoglycemia, if for any reason, a subject missed a meal, the dose of glulisine will be held. Glargine glulisine	70/30 Insulin Plus Supplemental Lunch Insulin n=21 participants at risk Modified split-mixed insulin protocol adopted by Umpierrez et al., will be applied to patients treated with 70/30 insulin. Insulin dose will be started at 0.4 U/kg/day for admission BG less than 200 mg/dL or 0.5 U/kg/day for BG above 200 mg/dL. Two thirds of total daily dose (TDD)will be given before breakfast and 1/3 of TDD before dinner. Supplemental lunchtime regular insulin dose will given for BG \> 150 mg/dL . Patients previously treated with 70/30 insulin before admission initially will receivethe same regimen as at in home. regular insulin 70/30 insulin	Sliding Scale Insulin (SSI) n=21 participants at risk；n=22 participants at risk For SSI group, regular insulin will be administered three times daily subcutaneously approximately 30 min before meal for BG \> 150 mg/dL (or every 8 hours if a patient was not eating) according to hospital sliding scale table regular insulin
Nervous system disorders Severe Hyperglcemia eposide	52.6% 10/19 • Number of events 22 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness	19.0% 4/21 • Number of events 8 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness	71.4% 15/21 • Number of events 30 • during hospital stay which is expected to be 3 weeks Major hypoglycemia (BG ≤ 40 mg/dL) associated with impaired mental status or loss of consciousness

Additional Information

Eman Said Sayed

Cairo University

Phone: 01001186079

Email: gaviota_3011@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place