Simplified Insulin Regimen for the Elderly

NCT03660553 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20180541
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age \>65 years) with type 2 diabetes.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Elderly; Insulin treatment; Quality of life

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c)

  The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group

  6 months

Secondary Outcomes (2)

• Incidence of Any Hypoglycemia

  6 months

• Incidence of Severe Hypoglycemia

  6 months

Study Arms (2)

Multiple Subcutaneous Injection (MSI)

ACTIVE COMPARATOR

MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro.

Drug: Insulin Glargine; Drug: Insulin Aspart; Drug: Insulin Lispro

Basal Insulin (BI)

EXPERIMENTAL

BI group will receive only one injection of insulin glargine in the morning.

Drug: Insulin Glargine

Interventions

Insulin Glargine DRUG

0.40 units/kg body weight

Basal Insulin (BI)

Insulin Aspart DRUG

0.20 units/kg body weight

Multiple Subcutaneous Injection (MSI)

Insulin Lispro DRUG

0.20 units/kg body weight

Multiple Subcutaneous Injection (MSI)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \>65 years

You may not qualify if:

• Unable to provide informed consent
• Enrollment in another research study
• History of hypoglycemia unawareness
• Pregnant women
• Prisoners

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

South Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Glargine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

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

This study was terminated and there was insufficient patient data for statistical analysis.

Results Point of Contact

• Title: Rajesh Garg
• Organization: The Lundquist Research Institute

rajesh.garg@lundquist.org

310-222-1968

Study Officials

• Rajesh Garg, MD

  University of Miami

  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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: October 10, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)