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The Inova Type 2 Diabetes Mellitus Study

NCT02222623 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-08-05

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and effectiveness of the two different basal insulins commonly used for basal blood sugar control in the treatment of type 2 diabetes mellitus in patients who are hospitalized and require low doses of insulin: neutral protamine Hagedorn (NPH) insulin and glargine (Lantus®) insulin. Previous research has shown that both NPH insulin and glargine (Lantus®) insulin is safe and effective for the control of blood sugar in a type 2 diabetic patient. This research is being done because the costs of medications for diabetic patients are very expensive. Our goal with this research is to show that a less expensive insulin (NPH) is as safe and effective as a more expensive insulin \[glargine (Lantus®)\] in patients with type 2 diabetes mellitus who are in the hospital.

Conditions

  • Diabetes, Type 2

Interventions

DRUG

Glargine

Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.

DRUG

NPH

NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Stephen C Clement, MD · Inova Fairfax Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02222623 on ClinicalTrials.gov