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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.

NCT ID: NCT00747383

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diabetes Mellitus GLP1 DPP4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

3mg oral tablet.

2

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

100mg oral tablet.

Interventions

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Glimepiride

3mg oral tablet.

Intervention Type DRUG

Sitagliptin

100mg oral tablet.

Intervention Type DRUG

Other Intervention Names

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Amaryl. Januvia.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Under 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The Royal Bournemouth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Kerr

Role: PRINCIPAL_INVESTIGATOR

Royal Bournemouth Hospital

Joseph Begley

Role: PRINCIPAL_INVESTIGATOR

Royal Bournemouth Hospital

Locations

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Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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08/H0201/57

Identifier Type: -

Identifier Source: org_study_id