NCT00747383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 5, 2012

Status Verified

September 1, 2008

Enrollment Period

2 years

First QC Date

September 4, 2008

Last Update Submit

December 4, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes MellitusGLP1DPP4

Outcome Measures

Primary Outcomes (1)

  • Comparison of GLP-1 response at baseline and after 3 months treatment of both groups.

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Glimepiride

2

ACTIVE COMPARATOR
Drug: Sitagliptin

Interventions

GlimepirideDRUG

3mg oral tablet.

Also known as: Amaryl.
1
SitagliptinDRUG

100mg oral tablet.

Also known as: Januvia.
2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

glimepirideSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • David Kerr

    Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

  • Joseph Begley

    Royal Bournemouth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 5, 2012

Record last verified: 2008-09

Locations

GB(1)