NCT00939939

Brief Summary

The goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

July 1, 2009

Enrollment Period

1.2 years

First QC Date

July 14, 2009

Last Update Submit

June 24, 2011

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • incremental area under the triglyceride curve (iAUC-TG)

    incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

    10 weeks

Secondary Outcomes (13)

  • LDL-cholesterol

    10 weeks

  • HDL-cholesterol

    10 weeks

  • VLDL-cholesterol

    10 weeks

  • triglycerides

    10 weeks

  • area under the triglyceride curve (AUC-TG)

    10 weeks

  • +8 more secondary outcomes

Study Arms (2)

sitagliptin

EXPERIMENTAL
Drug: sitagliptin

glimepirid

ACTIVE COMPARATOR
Drug: glimepiride

Interventions

sitagliptinDRUG

sitagliptin 100 mg/d for 10 weeks

sitagliptin
glimepirideDRUG

glimepiride 1 mg/d for 10 weeks

glimepirid

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • dietary therapy

You may not qualify if:

  • lipid-lowering therapy
  • anti-hyperglycemic drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Dept. 2, Grosshadern, University Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphateglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

March 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 27, 2011

Record last verified: 2009-07

Locations

DE(1)