Type 2 Diabetes Mellitus
Conditions
Brief summary
The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included. The primary outcome of the study is to determine difference in efficacy and security between a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes hospitalized in non-critical areas in a hospital in Mexico
Detailed description
On the first 4 to 6 h, the use of NPH insulin present a pronounced action peak on the postprandial glucose metabolism, and the rest of its basal action last 12 to 18 h, its cover the postprandial requirements of the first two meals of the day (breakfast and lunch) administering 2/3 of the total dose, and the requirements for the dinner with 1/3 of the total dose at the night. This is considered a good scheme for handling hyperglycemia, and its possible to have less hypoglycemia episodes, which are possible if an ultra-rapid-acting insulin is added and adequate intake is not performed due to multiple factors related to hospitalization. Today it is uncertain whether there is any clear benefit of using Glargine plus Lantus insulin over NPH insulin in hospitalized patients with type 2 diabetes. Currently, both Glargine and NPH based regimen is practiced in inpatient hospital facilities. Current practice of inpatient insulin regimen is based on the physicians familiarity with a particular insulin type and personal preference rather than evidenced based knowledge. Glargine plus ultrafast insulin are two types of insulin that are more expensive compared to NPH with incidental benefits in hospitalized patients. There are reports in the literature about the incidence of hypoglycemia with this scheme. The current research proposal is to compare these two schemes in the treatment of hospitalized patients with diabetes in a hospital of the second level of care in Mexico.
Interventions
DRUGNPH insulin
NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL.
DRUGGlargine and Lispro insulin
Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
Sponsors
Universidad de Guanajuato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 100 years old. * History of type 2 diabetes mellitus (DM2) or that upon admission is diagnosed by values of glycated haemoglobin (HbA1) \> 6.5% * Fasting central glucose before randomization between 140mg/dl and 400mg/dl * Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO). * Patients receiving a diabetic diet orally * Treated with diet alone, o any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.
Exclusion criteria
* Parenteral nutrition * Hyperglycemia without a known history of diabetes * Impaired renal function (glomerular filtration rate less than 30) * Diabetic ketoacidosis and hyperosmolar state * Type 1 Diabetes mellitus * Pregnancy * Patients on treatment with more than 10mg prednisone or steroid boluses. * Known hypopituitarism or adrenal insufficiency * Hyperglycaemia due to stress (negative antecedent of DM2, hyperglycemia and HbA1 \<6.5) * Severe liver disease (Child-Pugh C score) * Acute pancreatitis * Patients with sepsis or multiple organ failure * Candidates for intensive care unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week | To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Number of Participants With Mild and Severe Hypoglycemic Events | Duration of hospital stay, up to 4 weeks. | To measure the number of participants with mild and severe hypoglycemic events |
| Number of Participants With Sustained Glycemic Control During Hospital Stay | blood glucose was taken every day, up to 4 weeks. | Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay. |
Countries
Mexico
Participant flow
Recruitment details
A total of 111 hospitalized DM2 patients not critical to the study were evaluated. Of these, 35 did not meet the inclusion criteria and the 75 included participants were randomized into two groups. The recruitment of patients began on November 2, 2017 and ended on June 1, 2018.
Pre-assignment details
Within the basal-bolus group, 1 patient was eliminated before initiating the insulin regimen, presenting acute abdomen and requiring intensive therapy. Therefore, 36 patients will start treatment in the basal-bolus group and 39 patients in the NPH group.
Participants by arm
| Arm | Count |
|---|---|
| NPH Insulin Group Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin
NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose \>180 mg/dL. | 39 |
| Glargine and Lispro Insulin Group Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose \>180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro.
Intervention drug: Glargine and Lispro
Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. | 36 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | NPH Insulin Group | Glargine and Lispro Insulin Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 9 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 13.1 | 56.4 years STANDARD_DEVIATION 12.9 | 57.8 years STANDARD_DEVIATION 13 |
| Central glucose | 237.3 mg / dl STANDARD_DEVIATION 73.1 | 223.1 mg / dl STANDARD_DEVIATION 67 | 230.5 mg / dl STANDARD_DEVIATION 70.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 36 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico | 39 participants | 36 participants | 75 participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 19 Participants | 15 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 39 | 1 / 36 |
| other Total, other adverse events | 15 / 39 | 11 / 36 |
| serious Total, serious adverse events | 0 / 39 | 0 / 36 |
Outcome results
Primary
Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.
To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose.
Time frame: Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPH Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Fasting blood glucose | 129.6 mg/dl | Standard Deviation 23.6 |
| NPH Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Postprandial glucose | 155.4 mg/dl | Standard Deviation 29 |
| NPH Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Glucose in the early morning | 127.4 mg/dl | Standard Deviation 26.6 |
| Glargine and Lispro Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Fasting blood glucose | 135 mg/dl | Standard Deviation 22.6 |
| Glargine and Lispro Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Postprandial glucose | 156.2 mg/dl | Standard Deviation 27.2 |
| Glargine and Lispro Insulin Group | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | Glucose in the early morning | 136.2 mg/dl | Standard Deviation 21.2 |
Secondary
Number of Participants With Sustained Glycemic Control During Hospital Stay
Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay.
Time frame: blood glucose was taken every day, up to 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NPH Insulin Group | Number of Participants With Sustained Glycemic Control During Hospital Stay | 30 Participants |
| Glargine and Lispro Insulin Group | Number of Participants With Sustained Glycemic Control During Hospital Stay | 20 Participants |
Secondary
the Number of Participants With Mild and Severe Hypoglycemic Events
To measure the number of participants with mild and severe hypoglycemic events
Time frame: Duration of hospital stay, up to 4 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NPH Insulin Group | the Number of Participants With Mild and Severe Hypoglycemic Events | 15 Participants |
| Glargine and Lispro Insulin Group | the Number of Participants With Mild and Severe Hypoglycemic Events | 15 Participants |