Insulin for Hyperglycemia in Stroke Trial

NCT04834362 | Completed Phase 4 Results

• 1 other identifier: 108
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Glycemic control in acutely ill stroke patients with hyperglycemia is vital. Although insulin is the choice of anti-diabetic agent during acute stage, it is not clear which insulin regimen is better in terms of glycemic control and prevention of hypoglycemia in hospitalized acute stroke patients who are usually on small frequent nasogastric tube feeding. The present study aims to evaluate the efficacy and safety of human insulin (regular insulin and neutral protamine hagedorn, NPH insulin) to analog insulin (basal insulin glargine and rapid acting insulin aspart) in hospitalized acute stroke patients with hyperglycemia. Justification: Analog insulins are developed by minor alteration of the amino acid chain which alters their pharmacokinetics and make them more physiological. However, these insulins are costly and are not widely available. Conventional human insulins are more commonly used in our country. Comparison of these two regimen is necessary in our own setting to optimize optimal glycemic management of hospitalized acute stroke patients. Methodology: In this single-center, open-label, randomized trial, 100 patients with acute stroke and hyperglycemia (capillary blood glucose ≥10 mmol/L on 2 or more occasions) or history of type 2 DM admitted in the in-patient Department of Neurology, National Institute of Neurosciences (NINS) \& Hospital will be randomly assigned to receive human insulin or modern insulin therapy in 1:1 ratio. The study will be carried out from February to June 2021. Blood glucose (BG) will be monitored by standardized glucometer thrice a day and insulin dose will be adjusted daily. The primary outcome of the study will be the differences in glycemic control between groups, as measured by mean daily BG concentration during the hospital stay. Secondary outcomes include differences between treatment groups in any of the following measures: number of hypoglycemic events (BG \<3.9 mmol/L), total daily dose of insulin, length of hospital stay, hospital complications and mortality.

Conditions

Hyperglycemia; Stroke, Acute

Keywords

Hyperglycemia; Stroke; Human insulin; Analog insulin

Outcome Measures

Primary Outcomes (1)

• Glycemic Control

  Differences in glycemic control between groups, as measured by mean blood glucose concentration

  During the hospital stay assessed up to 10 days

Secondary Outcomes (3)

• Total Daily Dose of Insulin

  During the hospital stay assessed up to 10 days

• Length of Hospital Stay

  During the hospital stay assessed up to 10 days

• Mortality

  During the hospital stay assessed up to 10 days

Study Arms (2)

Analog insulin arm

EXPERIMENTAL

Patients treated with insulin analog regimen will receive 50% of total daily dose as basal insulin glargine at the same time of day and 50% as insulin aspart given in 3 equally divided doses at 6 am, 12 pm and 6 pm.

Drug: Analog Insulin

Human insulin arm

ACTIVE COMPARATOR

Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm

Drug: Human insulin

Interventions

Analog Insulin DRUG

For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG \>15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered. For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is \>10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG \>15 mmol/L.

Also known as: Insulin Aspart and Insulin Glargine

Analog insulin arm

Human insulin DRUG

Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.

Also known as: Regular insulin and NPH insulin

Human insulin arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to adult neurology ward with acute stroke with
• Patients having hyperglycemia (capillary blood glucose ≥10 mmol/L in 2 or more occasions or having history of treatment for DM)
• Patients with age of 18-80 years of both sexes
• Patients or their attendants giving consent to take part in the study

You may not qualify if:

• Patients with hyperglycemic emergencies (hyperglycemic hyperosmolar state or diabetic ketoacidosis)
• Pregnant patients
• Those not giving consent to participate in the study

Sponsors & Collaborators

• National Institute of Neurosciences and Hospital, Dhaka: lead

Study Sites (1)

National Institute of Neurosciences and Hospital

Dhaka, 1207, Bangladesh

Location

Related Publications (3)

• Chen R, Ovbiagele B, Feng W. Diabetes and Stroke: Epidemiology, Pathophysiology, Pharmaceuticals and Outcomes. Am J Med Sci. 2016 Apr;351(4):380-6. doi: 10.1016/j.amjms.2016.01.011.

  PMID: 27079344 BACKGROUND

• Bellolio MF, Gilmore RM, Ganti L. Insulin for glycaemic control in acute ischaemic stroke. Cochrane Database Syst Rev. 2014 Jan 23;2014(1):CD005346. doi: 10.1002/14651858.CD005346.pub4.

  PMID: 24453023 BACKGROUND

• Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.

  PMID: 31334795 RESULT

Related Links

• Website of the study site

MeSH Terms

Conditions

Hyperglycemia; Stroke; Insulin Resistance

Interventions

Insulin Aspart; Insulin Glargine; Insulin; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Mashfiqul Hasan
• Organization: National Institute of Neurosciences and Hospital, Dhaka

mashfiqul.hasan@nins.gov.bd

+8801816268746

Study Officials

• Mashfiqul Hasan, MD

  Assistant Professor (Endocrinology)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Endocrinology)

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 8, 2021
• Study Start: April 5, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 25, 2021
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)