NCT00225342

Brief Summary

The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes. Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2005

First QC Date

September 21, 2005

Last Update Submit

September 7, 2006

Conditions

Angina PectorisDiabetes Mellitus, Type 2

Keywords

AnginaIschaemic heart diseaseDiabetes

Outcome Measures

Primary Outcomes (1)

  • Angina status at 3 months

Secondary Outcomes (4)

  • Pulse wave velocity at 3 months

  • Small vessel function at 3 months

  • Haemostatic markers at 3 months

  • Biochemical markers of inflammation at 3 months

Interventions

RosiglitazoneDRUG
Gliclazide (Comparison drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
  • Participants will have uncontrolled diabetes (Hba1c\>7.5) on metformin monotherapy (so the diabetes is not over treated)
  • Participants will be diabetic for less than 8 years.

You may not qualify if:

  • Renal impairment (creatinine \>130mmol/l)
  • Hepatic Impairment (ALT\>70U/l, AST\>80U/l)
  • Any clinical signs of heart failure
  • Physical disability precluding treadmill exercise tolerance testing
  • Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
  • Women of childbearing potential
  • Women who are breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Angina PectorisDiabetes Mellitus, Type 2Coronary Artery DiseaseDiabetes Mellitus

Interventions

RosiglitazoneGliclazide

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfones

Study Officials

  • Naveed Sattar, MBChB PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

  • Stuart M Cobbe, MBChB MD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Last Updated

September 8, 2006

Record last verified: 2005-09

Locations

GB(1)