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)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by The Royal Bournemouth Hospital. Recruitment status was Recruiting

First Received on September 4, 2008. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Glucagon Glucagon-like peptide 1 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
Active Comparator: 1	Drug: Glimepiride 3mg oral tablet. Other Name: Amaryl.
Active Comparator: 2	Drug: Sitagliptin 100mg oral tablet. Other Name: Januvia.

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
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:	Professor David Kerr DM FRCP FRCPE, Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:	NCT00747383 History of Changes
Other Study ID Numbers:	08/H0201/57
Study First Received:	September 4, 2008
Last Updated:	September 25, 2008
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:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012