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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747383
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : December 5, 2012
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

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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 ]

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT00747383

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

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Responsible Party: The Royal Bournemouth Hospital 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
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