How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin. - Full Text View

How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin. (MSD-GLP1)

This study is currently recruiting participants.

Verified by The Royal Bournemouth Hospital, September 2008

First Received: September 4, 2008 Last Updated: September 25, 2008 History of Changes

Sponsor:	The Royal Bournemouth Hospital
Collaborator:	Merck
Information provided by:	The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:	NCT00747383

Purpose

The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains poorly controlled. There are two additional medications already in use, Glimepiride and Sitagliptin will be compared to assess levels of improvement in Diabetes control.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: Glimepiride Drug: Sitagliptin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Influence of Improving Glycaemic Control on Glucagon-Like-Peptide-1 Response to an Oral Glucose Load. Comparison of Sulphonylurea With DPP-4 Inhibition.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:

Comparison of GLP-1 response at baseline and after 3 months treatment of both groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	74
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Glimepiride 3mg oral tablet.
2: Active Comparator	Drug: Sitagliptin 100mg oral tablet.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetes Mellitus
Currently on Metformin but poor glycaemic control,

Exclusion Criteria:

Under 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747383

Contacts

Contact: David Kerr	01202 704603	david.kerr@rbch.nhs.uk
Contact: Ros Everdell	01202 704344

Locations

United Kingdom, Dorset
Royal Bournemouth Hospital	Recruiting
Bournemouth, Dorset, United Kingdom, BH7 7DW
Principal Investigator: David Kerr, MD

Sponsors and Collaborators

The Royal Bournemouth Hospital

Merck

Investigators

Principal Investigator:	David Kerr	Royal Bournemouth Hospital.
Principal Investigator:	Joseph Begley	Royal Bournemouth Hospital

More Information

No publications provided

Responsible Party:	Royal Bournemouth Hospital ( Professor David Kerr DM FRCP FRCPE )
Study ID Numbers:	08/H0201/57
Study First Received:	September 4, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00747383 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by The Royal Bournemouth Hospital:

Diabetes Mellitus
GLP1
DPP4

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions

Protease Inhibitors
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010