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 has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00747383
First received: September 4, 2008
Last updated: December 4, 2012
Last verified: September 2008
  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:


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 ]

Enrollment: 74
Study Start Date: September 2008
Study Completion Date: September 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: The 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: December 4, 2012
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 July 28, 2014