Insulin Schemes for Type 2 Diabetes Control

NCT03350984 | Completed Phase 4 Results DMC

• 1 other identifier: SSGTO00136
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (2)

• the Number of Participants With Mild and Severe Hypoglycemic Events

  Duration of hospital stay, up to 4 weeks.

• Number of Participants With Sustained Glycemic Control During Hospital Stay

  blood glucose was taken every day, up to 4 weeks.

Study Arms (2)

NPH insulin group

EXPERIMENTAL

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

Glargine and Lispro insulin group

ACTIVE COMPARATOR

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

Interventions

NPH insulin DRUG

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.

Also known as: NPH

NPH insulin group

Glargine and Lispro insulin DRUG

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.

Also known as: Glargine and Lispro

Glargine and Lispro insulin group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

Hospital General de León

León, Guanajuato, 37680, Mexico

Location

Related Publications (3)

• Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.

  PMID: 21228246 BACKGROUND

• Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

  PMID: 23435159 BACKGROUND

• Christensen MB, Gotfredsen A, Norgaard K. Efficacy of basal-bolus insulin regimens in the inpatient management of non-critically ill patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2017 Jul;33(5). doi: 10.1002/dmrr.2885. Epub 2017 Feb 23.

  PMID: 28067472 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin, Isophane; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

Although the patients had an oral diet, the prolonged stay due to complications not associated with DM2 reduced their caloric intake. The physiological scheme is more demanding, making it difficult to stick to the ideal conditions of the study.

Results Point of Contact

• Title: Dra. Paulina Crespo Morfin
• Organization: University of Guanajuato

pb.crespomorfin@outlook.es

+52 4431300112

Study Officials

• Jose A Alvarez, PhD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 22, 2017
• Study Start: November 2, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 6, 2021
• Results First Posted: January 18, 2020

Record last verified: 2021-11

Locations

ME (1)