ClinicalTrials.Veeva

Menu

Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402) (NEEDS)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Metformn
Drug: Sulphonylurea

Study type

Observational

Funder types

Industry

Identifiers

NCT01278485
0431-402

Details and patient eligibility

About

This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment.

The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.

Enrollment

726 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Participants diagnosed with type 2 diabetes mellitus (DM).
  • Participants at least 30 years of age at time of type 2 DM diagnosis.
  • Participants treated with SU monotherapy or SU + MF combination therapy for at least 6 months prior to enrollment.
  • Participants receiving diabetes care from a cardiologist, nephrologist or family practitioner for at least 6 months.
  • Participants with a clinical record in the health care center.
  • Participants in whose medical records a minimum core data set can be found; core data defined as: age, gender, duration of diabetes/age at diagnosis, all glucose-lowering medications (branded and generic names, dosage, dosing frequency, starting and stopping dates) since the start of all antihyperglycemic medications.

Exclusion Criteria

  • Participants with Type 1 DM.
  • Participants who are pregnant or with gestational DM.
  • Participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months.
  • Participants requiring daily concomitant usage of insulin.
  • Participants receiving any other oral diabetes medications other than SU or SU + MF.
  • Participants who are already participating in a clinical trial or other clinical study.
  • Participants for whom it would be impossible to complete the questionnaire.

Trial design

726 participants in 1 patient group

Sulphonylurea (SU) Monotherapy or SU + Metformin
Description:
Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
Treatment:
Drug: Sulphonylurea
Drug: Metformn

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems