Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.
Interventions
DRUGinsulin aspart
insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
DRUGinsulin detemir
insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.
Sponsors
Novo Nordisk A/S
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years 2. History of type 2 diabetes mellitus for at least 3 months 3. Prior therapy with dietary management, oral agents, or insulin 4. Non child-bearing potential or a negative urine pregnancy test 5. Initial blood glucose in ER \> 200 mg/dl
Exclusion criteria
1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation. 2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention. 3. History of current drug or alcohol abuse. 4. History of current mental illness 5. Inability to give informed consent 6. Female patients who are pregnant or are breast feeding 7. Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal 8. Patients currently treated with dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | from hospital admission to hospital discharge | hospital length of stay in days |
Secondary
| Measure | Time frame |
|---|---|
| Average Blood Glucose During the Hospital Admission | from admission to discharge |
| Frequency of Hypoglycemia | from hospital admission to discharge |
| Efficacy of Blood Glucose Lowering During the Emergency Room Stay | from emergency room admission to discharge |
| Frequency of Hypoglycemia During Emergency Room Therapy With Insulin | from emergency room admission to discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspart Detemir these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating. | 89 |
| Usual Care these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference. | 87 |
| Total | 176 |
Baseline characteristics
| Characteristic | Usual Care | Aspart Detemir | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 68 Participants | 136 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 87 participants | 89 participants | 176 participants |
| Sex: Female, Male Female | 53 Participants | 46 Participants | 99 Participants |
| Sex: Female, Male Male | 34 Participants | 43 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 89 | 0 / 87 |
| serious Total, serious adverse events | 0 / 89 | 0 / 87 |
Outcome results
Primary
Hospital Length of Stay
hospital length of stay in days
Time frame: from hospital admission to hospital discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aspart Detemir | Hospital Length of Stay | 2.7 days |
| Usual Care | Hospital Length of Stay | 3.1 days |
p-value: 0.58t-test, 1 sided
Secondary
Average Blood Glucose During the Hospital Admission
Time frame: from admission to discharge
Population: PI no longer at institution, study is over 10 years old, data unavailable.
Secondary
Efficacy of Blood Glucose Lowering During the Emergency Room Stay
Time frame: from emergency room admission to discharge
Population: PI no longer at institution, study is over 10 years old, data unavailable.
Secondary
Frequency of Hypoglycemia
Time frame: from hospital admission to discharge
Population: PI no longer at institution, study is over 10 years old, data unavailable.
Secondary
Frequency of Hypoglycemia During Emergency Room Therapy With Insulin
Time frame: from emergency room admission to discharge
Population: PI no longer at institution, study is over 10 years old, data unavailable.