Phase 4 Completed N=65 Treatment

Simplified Insulin Protocol Using Lantus in Elderly

Diabetes

Source: ClinicalTrials.gov NCT01480843 ↗

Enrolled (actual)

Serious AEs

27.7%

Results posted

Nov 2017

Primary outcomePrimary: Change in Duration of Hypoglycemia Episodes — 277; 111; 97 minutes of hypoglycemia

Summary

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Duration of Hypoglycemia Episodes	277; 111; 97	—
PRIMARY Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months	4.3; 1.8; 1.5	—

Eligibility Criteria

Inclusion Criteria

Age 70 years or older
Diagnosis of diabetes mellitus Type II
At least 2 (short-acting or mixed) insulin injections per day
At least 1 episode of hypoglycemia (glucose value 3 times normal)
On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)
Malignancy that limits life span to less than 18 months
Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01480843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.