NCT03660553

Simplified Insulin Regimen for the Elderly

Terminated Phase 4 Results posted Last updated 12 December 2023

What this trial tests

Phase 4 trial testing Insulin Glargine in Type 2 Diabetes Mellitus in 7 participants. Terminated before completion.

Timeline

10 October 2018

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	10 October 2018
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Insulin Glargine (INSULIN GLARGINE) — full drug profile →
• Insulin Glargine (INSULIN GLARGINE) — full drug profile →
• Insulin Aspart (INSULIN ASPART) — full drug profile →
• Insulin Lispro (INSULIN LISPRO) — full drug profile →

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

University of Miami

Who can join

65 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hemoglobin A1c (HbA1c) Primary · 6 months

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

Group	Value	95% CI
Multiple Subcutaneous Injection (MSI)	8.5	7.4 – 9.7
Basal Insulin (BI)	7.8	7.6 – 8

Incidence of Any Hypoglycemia Secondary · 6 months

Defined as any reported blood glucose (BG) \<70 mg/dl will be compared between the two groups

Group	Value	95% CI
Multiple Subcutaneous Injection (MSI)	0
Basal Insulin (BI)	0

Incidence of Severe Hypoglycemia Secondary · 6 months

Any BG \<54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.

Group	Value	95% CI
Multiple Subcutaneous Injection (MSI)	0
Basal Insulin (BI)	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.