Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date December 5, 2012
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Comparison of GLP-1 response at baseline and after 3 months treatment of both groups. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00747383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.
Official Title  ICMJE Influence of Improving Glycaemic Control on Glucagon-Like-Peptide-1 Response to an Oral Glucose Load. Comparison of Sulphonylurea With DPP-4 Inhibition.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Glimepiride
    3mg oral tablet.
    Other Name: Amaryl.
  • Drug: Sitagliptin
    100mg oral tablet.
    Other Name: Januvia.
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Glimepiride
  • Active Comparator: 2
    Intervention: Drug: Sitagliptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2008)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747383
Other Study ID Numbers  ICMJE 08/H0201/57
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Royal Bournemouth Hospital
Study Sponsor  ICMJE The Royal Bournemouth Hospital
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: David Kerr Royal Bournemouth Hospital
Principal Investigator: Joseph Begley Royal Bournemouth Hospital
PRS Account The Royal Bournemouth Hospital
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP