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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)

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ClinicalTrials.gov Identifier: NCT00747383
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : December 5, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
The Royal Bournemouth Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Glimepiride Drug: Sitagliptin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 Drug: Glimepiride
3mg oral tablet.
Other Name: Amaryl.

Active Comparator: 2 Drug: Sitagliptin
100mg oral tablet.
Other Name: Januvia.




Primary Outcome Measures :
  1. Comparison of GLP-1 response at baseline and after 3 months treatment of both groups. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Mellitus
  • Currently on Metformin but poor glycaemic control,

Exclusion Criteria:

  • Under 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747383


Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: David Kerr Royal Bournemouth Hospital
Principal Investigator: Joseph Begley Royal Bournemouth Hospital

Responsible Party: The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier: NCT00747383     History of Changes
Other Study ID Numbers: 08/H0201/57
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: September 2008

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 Phosphate
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors