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Traditional Insulin Scheme for Glycemic Control in Non-Critically Inpatients With Diabetes Mellitus 2

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ClinicalTrials.gov Identifier: NCT03350984
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Jose Antonio de Jesus Alvarez Canales, Universidad de Guanajuato

Brief Summary:

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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 2, 2018
Actual Primary Completion Date : July 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of mild and severe hypoglycemic events. [ Time Frame: Duration of hospital stay, up to 4 weeks. ]
    To measure the number of hypoglycemic events.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between 18 and 80 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

Information from the National Library of Medicine

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


Contacts
Contact: Paulina B Crespo, MD 4431300112 pb.crespomorfin@ugto.mx

Locations
Mexico
Hospital General de León Recruiting
León, Guanajuato, Mexico, 37680
Contact: Paulina B. Crespo, MD    52 4431300112    pb.crespomorfin@ugto.mx   
Contact: Paulina B. Crespo, MD    52 3945344743    crespau.snoop@gmail.com   
Principal Investigator: Jose A Alvarez, PhD         
Hospital General de León Recruiting
León, Guanajuato, Mexico, 37680
Contact: José de Jesus Alvarez, Médico    524772594598    alvarez_ja@me.com   
Contact: Jesus Alberto López, Médico    524771299879    jealg@prodigy.net.mx   
Sponsors and Collaborators
Universidad de Guanajuato
Investigators
Principal Investigator: Jose A Alvarez, PhD Universidad de Guanajuato

Publications:
Responsible Party: Jose Antonio de Jesus Alvarez Canales, PhD, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03350984     History of Changes
Other Study ID Numbers: SSGTO00136
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs