Study Protocol for Rosiglitazone Versus Gliclazide in Dia... | NCT00225342

Studies
Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina

NCT00225342

Sponsor

University of Glasgow

Status

Withdrawn

Last Update Posted

Sep 8, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Angina Pectoris
Diabetes Mellitus, Type 2

Interventions

Rosiglitazone
Gliclazide (Comparison drug)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Eudract No. 2004-000943-40

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2006

Last Update Posted Date

Sep 8, 2006Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

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.

Detailed Description

Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.

We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c >7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.

We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Angina status at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Pulse wave velocity at 3 months
Small vessel function at 3 months
Haemostatic markers at 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Naveed Sattar, MBChB PhD	University of Glasgow	Principal Investigator
Stuart M Cobbe, MBChB MD	University of Glasgow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Department, Glasgow Royal Infirmary		Glasgow		G4 0SF	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000787	Angina Pectoris
D003924	Diabetes Mellitus, Type 2
D003324	Coronary Artery Disease
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077154	Rosiglitazone
D005907	Gliclazide

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Rosiglitazone	Drug
Gliclazide (Comparison drug)	Drug