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Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes

NCT00869414 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-06-29

Study results available
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Summary

This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

Conditions

Interventions

DRUG

Evening only administration of insulin glargine

Evening only administration of insulin glargine, with normal saline injection administered in the morning.

DRUG

Morning only administration of insulin glargine

Morning only administration of insulin glargine, with normal saline injection administered at night.

DRUG

split dose insulin glargine

split dose of insulin glargine, half administered in the morning, half administered in evening

Sponsors & Collaborators

Principal Investigators

  • Christopher D Saudek, MD · Johns Hopkins University

  • Ari S Eckman, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00869414 on ClinicalTrials.gov