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Effect of Sitagliptin on Postprandial Lipoprotein Metabolism

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00939939
Enrollment
3
Registered
2009-07-15
Start date
2010-03-31
Completion date
2011-05-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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

Interventions

DRUGsitagliptin

sitagliptin 100 mg/d for 10 weeks

DRUGglimepiride

glimepiride 1 mg/d for 10 weeks

Sponsors

Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* type 2 diabetes * dietary therapy

Exclusion criteria

* lipid-lowering therapy * anti-hyperglycemic drug therapy

Design outcomes

Primary

MeasureTime frameDescription
incremental area under the triglyceride curve (iAUC-TG)10 weeksincremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge

Secondary

MeasureTime frameDescription
HDL-cholesterol10 weeksfasting HDL-cholesterol
VLDL-cholesterol10 weeksfasting VLDL-cholesterol
triglycerides10 weeksfasting triglycerides
area under the triglyceride curve (AUC-TG)10 weeksarea under the plasma triglyceride concentration curve following a standardized oral fat challenge
area under the VLDL-triglyceride curve (AUC-VLDL-TG)10 weeksarea under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG)10 weeksincremental area under the plasma VLDL-triglyceride concentration curve following a standardized oral fat challenge
LDL-cholesterol10 weeksfasting LDL-cholesterol
insulin10 weeksfasting insulin concentration
HOMA10 weeks—
HbA1c10 weeks—
interleukin-610 weeks—
hs-CRP10 weeks—
glucose10 weeksfasting glucose concentration

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026