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CompletedNCT01176656Updated Sep 13, 2011

Hypoglycemia: Physician and Patient Perspectives

An observational study in Type 2 Diabetes Mellitus and Hypoglycemia, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-13.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Hypoglycemia

Keywords

  • Type 2 Diabetes Mellitus
  • Hypoglycemia
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 800 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.

Inclusion criteria

  • T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
  • at least 1 HbA1c test recorded during the identification period
  • continuous enrollment in the health plan for at least 12 months prior to survey date

Exclusion criteria

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • pregnancy or gestational diabetes
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
800 participants (actual)

Groups and cohorts

  • SU

    T2DM patients with a prescription for a sulfonylurea but no insulin

  • Antidiabetic without SU

    T2DM patients with an oral antidiabetic drug other than an SU, and no insulin

  • Insulin

    T2DM patients using insulin, with or without other oral antidiabetics

06

What researchers measure

Primary outcomes

  1. prevalence of hypoglycemia and impact of hypoglycemia

    Time frame: October 2009-October 2010

Secondary outcomes

  1. Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)

    Time frame: October 2009-October 2010

  2. Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization

    Time frame: October 2009-October 2010

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01176656
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 6, 2010
Start date
Sep 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Sep 13, 2011

Study contacts

Setareh Williams, PhD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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