Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, inpatient hyperglycemia, SQ insulin, Hospitalized patients with type 2 diabetes
Brief summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.
Interventions
DRUGDetemir + aspart insulin before meals
Detemir insulin SQ once daily + aspart insulin SQ before meals
DRUGNPH insulin + regular insulin
NPH insulin SQ + regular insulin SQ before breakfast and dinner
Sponsors
Novo Nordisk A/S
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between the ages of 18 and 70 years admitted to a general medical service. 2. A known history of type 2 diabetes mellitus \> 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy. 3. Subjects must have an admission blood glucose \> 140 mg and \< 400 mg/dL and no evidence of ketoacidosis (serum bicarbonate \< 18 mEq/L, venous or arterial pH \< 7.30, positive serum or urinary ketones).
Exclusion criteria
1. Subjects with increased blood glucose concentration, but without a known history of diabetes. 2. Subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[63\]. 3. Patients with acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), or to undergo surgery during the hospitalization course. 4. Patients with clinically relevant hepatic disease (ALT 2.5x \> upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥ 1.8 mg/dL for females. 5. History of drug or alcohol abuse within the last 2 years. 6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 7. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism. 8. Female subjects are pregnant or breast feeding at time of enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean AM BG (mg/dl) | during hospitalization | average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hypoglycemic Events | during hospitalization | number of patients with hypoglycemic events as defined as BG 40-59 mg/dl |
Countries
United States
Participant flow
Recruitment details
This study was conducted at Grady Memorial Hospital in Atlanta, GA and at Rush University Medical Center, Chicago, IL. IRB approval was given at each center and consent was obtained from all subjects. Patients with a h/o T2DM were recruited in 2007.
Participants by arm
| Arm | Count |
|---|---|
| Detemir + Aspart Detemir insulin once daily + aspart insulin before meals | 67 |
| NPH+Regular NPH insulin + regular insulin before breakfast and dinner | 63 |
| Total | 130 |
Baseline characteristics
| Characteristic | NPH+Regular | Detemir + Aspart | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 60 Participants | 117 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 63 participants | 67 participants | 130 participants |
| Sex: Female, Male Female | 33 Participants | 37 Participants | 70 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 63 |
| serious Total, serious adverse events | 15 / 67 | 13 / 63 |
Outcome results
Primary
Mean AM BG (mg/dl)
average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2
Time frame: during hospitalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Detemir + Aspart | Mean AM BG (mg/dl) | 144 mg/dl | Standard Deviation 56 |
| NPH+Regular | Mean AM BG (mg/dl) | 155 mg/dl | Standard Deviation 62 |
Secondary
Number of Patients With Hypoglycemic Events
number of patients with hypoglycemic events as defined as BG 40-59 mg/dl
Time frame: during hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Detemir + Aspart | Number of Patients With Hypoglycemic Events | 15 participants |
| NPH+Regular | Number of Patients With Hypoglycemic Events | 13 participants |