Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Type 2, insulin, therapy
Brief summary
Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: * To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. * To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.
Detailed description
By doing this study, we hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty-four weeks after discharge from the hospital.
Interventions
DRUGNPH/Regular 70/30 mix
injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
DRUGinsulin aspart protamine/insulin aspart 70/30 mix
injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
Sponsors
Novo Nordisk A/S
Dennis G. Karounos, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes for duration of three-months or longer * greater than or equal to 40 years of age * Written informed consent to participate in the study * Admitted for hospitalization at VA Medical Center Lexington, KY * Able and willing to do the following: * Use the insulin injection device provided to you as you are instructed * Check your blood sugar as instructed using the blood sugar monitor and send the results by a glucose log or a telephone transmitter provided to you for use during the study * Enter your information in a diary provided to you * You have an acute non-critical medical illness requiring inpatient hospitalization (at least 24 hour admission) with a blood glucose between 140 and 400 mg/dl. * You require further hospitalization after being released from intensive care unit for an acute illness
Exclusion criteria
* Have developed a severe illness requiring treatment in an intensive care unit as determined by your admitting physician. * Are pregnant or intend to become pregnant during this study, or are a sexually active woman who could become pregnant and are not practicing a birth control method considered acceptable by your study doctor for preventing pregnancy. * Are a woman who is breastfeeding. * Have a history of heart disease that limits your physical activity * Have had a kidney transplant or are currently receiving kidney dialysis * Have history of cancer other than minor skin cancer. * Have had a blood transfusion or severe loss of blood in the past 3 months or have any disease of the blood system. * Are allergic or sensitive to study insulin. * Are currently receiving oral steroid therapy. * Are currently on any other investigational medications or investigational protocols * Have drug or alcohol abuse that in the investigator's opinion would cause the individual to be non-compliant. * Are poorly compliant with the currently prescribed diabetes regimen or self monitoring of blood glucose, as defined by the investigator. * Have a mental condition that renders you unable to understand the scope and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase. | 16 weeks | Hemoglobin A1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seven Point Blood Glucose Profiles | 2 weeks | mg/dl |
| Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control | 16 weeks | — |
| Hypoglycemia | daily | — |
| Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter | daily | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NPH/Regular 70/30 Mix transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness
NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration | 50 |
| Aspart Insulin Analog Biphasic Mix transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness
insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks | 64 |
| Total | 114 |
Baseline characteristics
| Characteristic | NPH/Regular 70/30 Mix | Aspart Insulin Analog Biphasic Mix | Total |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 9 | 62.8 years STANDARD_DEVIATION 8.6 | 63.8 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 50 Participants | 62 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 50 | 9 / 64 |
| serious Total, serious adverse events | 15 / 50 | 10 / 64 |
Outcome results
Primary
For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase.
Hemoglobin A1c
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPH/Regular 70/30 Mix | For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase. | 8.32 % hemoglobin A1c | Standard Deviation 1.5 |
| Aspart Insulin Analog Biphasic Mix | For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase. | 8.35 % hemoglobin A1c | Standard Deviation 1.95 |
Secondary
Hypoglycemia
Time frame: daily
Secondary
Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Time frame: 16 weeks
Secondary
Seven Point Blood Glucose Profiles
mg/dl
Time frame: 2 weeks
Secondary
Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Time frame: daily