Traditional Insulin Scheme for Glycemic Control in Non-Critically Inpatients With Diabetes Mellitus 2
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|ClinicalTrials.gov Identifier: NCT03350984|
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : August 31, 2018
The aim of the study is to determine differences in glycemic control between a traditional regimen with Neutral Protamine Hagedorn insulin (NPH) and a "physiological" regimen or basal bolus regimen with glargine and lispro insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility. 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 the treatment groups as measured by the mean daily blood glucose (efficacy is normoglycemia and number of days in glycemic control during the hospital stay; security is hypoglycemic events and complication diabetes mellitus associated).
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: NPH insulin Drug: Glargine and Lispro insulin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of Efficacy and Safety of a "Physiological" Insulin Scheme vs Traditional Scheme for Glycemic Control in Non-Critically Inpatients With Diabetes Mellitus 2.|
|Actual Study Start Date :||November 2, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||July 1, 2018|
Experimental: 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
Drug: 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.
Other Name: NPH
Active Comparator: 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
Drug: 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.
Other Name: Glargine and Lispro
- Differences in glycemic control between a physiological and traditional schemes of insulin as measured by the mean daily blood glucose. [ Time Frame: Duration of hospital stay, up to 4 weeks. ]To determine the differences in glycemic control between a physiological and traditional schemes of insulin measured by the mean daily blood glucose.
- Number of mild and severe hypoglycemic events. [ Time Frame: Duration of hospital stay, up to 4 weeks. ]To measure the number of hypoglycemic events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350984
|Hospital General de León|
|León, Guanajuato, Mexico, 37680|
|Principal Investigator:||Jose A Alvarez, PhD||Universidad de Guanajuato|