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NCT00747383 Clinical Trial

How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.

Type 2 Diabetes Mellitus Clinical Trial

— MSD-GLP1  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00747383
Other study ID # 08/H0201/57
Secondary ID
Status Completed
Phase N/A
First received September 4, 2008
Last updated December 4, 2012
Start date September 2008
Est. completion date September 2010

Study information
Verified date September 2008
Source The Royal Bournemouth Hospital
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diabetes Mellitus

- Currently on Metformin but poor glycaemic control,

Exclusion Criteria:

- Under 18 years of age

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Glimepiride
3mg oral tablet.
• Sitagliptin
100mg oral tablet.

Locations
Country Name City State
United Kingdom Royal Bournemouth Hospital Bournemouth Dorset

Sponsors (2)
Lead Sponsor Collaborator
The Royal Bournemouth Hospital Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of GLP-1 response at baseline and after 3 months treatment of both groups. 2 years No
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