Diabetes Mellitus (DM)
Conditions
Keywords
Type 2 D M, sliding scale insulin, 70/30 insulin, basals insulin, supplemental insulin
Brief summary
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes. Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
Interventions
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* known history of type 2 DM for longer than 3 months * age between 18-64 year old, * treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.
Exclusion criteria
* subjects with hyperglycemia without any known history of DM * presence of diabetic ketoacidosis (DKA) * patients admitted to intensive care unit (ICU) * subjects expected to undergo surgery during the hospitalization course * patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | during hospital stay which is expected to be average 3 weeks |
| Mean BG After First Day of Hospitalization | after first day of hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Developed Hypoglycemic Events | 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. |
| Number of Patients Developed Episodes of Severe Hyperglycemia | during hospital stay which is expected to be average 3 weeks | Hyperglycemic events are defined as BG \> 300 mg/dL. |
| Mortality Rate | during the hospital stay which is expected to be average 3 weeks | — |
Countries
Egypt
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 21 |
| 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 | 22 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | develpoed diabetic ketoacidosis | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Glargine Plus Supplemental Glulisine | 70/30 Insulin Plus Supplemental Lunch Insulin | Sliding Scale Insulin (SSI) | Total |
|---|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 7 | 55 years STANDARD_DEVIATION 7 | 55 years STANDARD_DEVIATION 9 |
| BMI | 31 Kg/m2 STANDARD_DEVIATION 6 | 31 Kg/m2 STANDARD_DEVIATION 7 | 31 Kg/m2 STANDARD_DEVIATION 5 | 31 Kg/m2 STANDARD_DEVIATION 5 |
| Body weight | 75 Kg STANDARD_DEVIATION 11 | 78 Kg STANDARD_DEVIATION 20 | 73 Kg STANDARD_DEVIATION 12 | 76 Kg STANDARD_DEVIATION 15 |
| Region of Enrollment Egypt | 19 participants | 21 participants | 22 participants | 62 participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 15 Participants | 41 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 19 | 4 / 21 | 15 / 21 |
| serious Total, serious adverse events | 2 / 19 | 0 / 21 | 0 / 22 |
Outcome results
Primary
Mean BG After First Day of Hospitalization
Time frame: after first day of hospitalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glargine Plus Supplemental Glulisine | Mean BG After First Day of Hospitalization | 225 mg/dL | Standard Deviation 65 |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Mean BG After First Day of Hospitalization | 171 mg/dL | Standard Deviation 38 |
| Sliding Scale Insulin (SSI) | Mean BG After First Day of Hospitalization | 218 mg/dL | Standard Deviation 71 |
Primary
Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.
Time frame: during hospital stay which is expected to be average 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glargine Plus Supplemental Glulisine | Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | 221 mg/dL | Standard Deviation 67 |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | 179 mg/dL | Standard Deviation 36 |
| Sliding Scale Insulin (SSI) | Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. | 222 mg/dL | Standard Deviation 67 |
Secondary
Mortality Rate
Time frame: during the hospital stay which is expected to be average 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glargine Plus Supplemental Glulisine | Mortality Rate | 0 participants |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Mortality Rate | 0 participants |
| Sliding Scale Insulin (SSI) | Mortality Rate | 0 participants |
Secondary
Number of Patients Developed Episodes of Severe Hyperglycemia
Hyperglycemic events are defined as BG \> 300 mg/dL.
Time frame: during hospital stay which is expected to be average 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glargine Plus Supplemental Glulisine | Number of Patients Developed Episodes of Severe Hyperglycemia | 10 participants |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Number of Patients Developed Episodes of Severe Hyperglycemia | 4 participants |
| Sliding Scale Insulin (SSI) | Number of Patients Developed Episodes of Severe Hyperglycemia | 15 participants |
Secondary
Number of Patients Developed Hypoglycemic Events
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.
Time frame: during hospital stay which is expected to be average 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glargine Plus Supplemental Glulisine | Number of Patients Developed Hypoglycemic Events | Minor (BG between 40 - 59 mg/dL | 3 participants |
| Glargine Plus Supplemental Glulisine | Number of Patients Developed Hypoglycemic Events | Major (BG ≤ 40 mg/dL) | 2 participants |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Number of Patients Developed Hypoglycemic Events | Minor (BG between 40 - 59 mg/dL | 0 participants |
| 70/30 Insulin Plus Supplemental Lunch Insulin | Number of Patients Developed Hypoglycemic Events | Major (BG ≤ 40 mg/dL) | 0 participants |
| Sliding Scale Insulin (SSI) | Number of Patients Developed Hypoglycemic Events | Minor (BG between 40 - 59 mg/dL | 1 participants |
| Sliding Scale Insulin (SSI) | Number of Patients Developed Hypoglycemic Events | Major (BG ≤ 40 mg/dL) | 0 participants |