Phase 4 N=21 Treatment

U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

Type 2 Diabetes · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT00606034 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Dec 2013

Primary outcome: Primary: Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) — -1.23 HbA1c percentage

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: U-500 Insulin delivered by Omnipod (disposable insulin pump) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mountain Diabetes and Endocrine Center
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)	-1.23	—
SECONDARY Percentage of Time Spent in Hypoglycemia	-3.7	—
SECONDARY Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)	90.68	—

Summary

Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months
HbA1c > 7%
No significant cardiovascular, renal or other serious medical diseases

Exclusion Criteria

HbA1c < 7%
Chronic renal, hepatic, cardiovascular, or other serious medical illness
Females of childbearing age not using adequate contraception
Use of GLP mimetic

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00606034). 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.