NCT00734669

Brief Summary

The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

7.5 years

First QC Date

August 13, 2008

Last Update Submit

October 24, 2016

Conditions

Type 2 Diabetes

Keywords

DiabetesHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Number of hypoglycemic events

    3 days

Secondary Outcomes (1)

  • Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia

    3 days

Study Arms (1)

1

Type 2 diabetic patients on glibenclamide at individual dosage up to 7 mg/day for more than one year prone to hypoglycemic events

Drug: Glibenclamide

Interventions

GlibenclamideDRUG

Taking a single dose of 3.5 mg glibenclamide

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetes

You may qualify if:

  • Type 2 diabetes on glibenclamide with or without
  • Glycated hemoglobin ≤ 7.5%
  • Stable dosage for three weeks

You may not qualify if:

  • HbA1c \> 7.5%
  • Fasting C-peptide below normal
  • Concurrent infectious disease
  • Pregnancy
  • Malignant disease
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusHypoglycemia

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2016

Study Completion

October 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share