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Phase 2 Completed N=80 Randomized Double-blind Treatment

Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00758069 ↗
Enrolled (actual)
80
Serious AEs
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in 24-hour Weighted Mean Plasma Glucose — -34.9; -28.6; -9.0 mg/dL — p=<0.001

Summary

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in 24-hour Weighted Mean Plasma Glucose
-34.9; -28.6; -9.0 <0.001 sig
SECONDARY
Change From Baseline in Plasma Glucose
-22.3; -16.0; -3.1 <0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria

  • Patients Have Type 1 Diabetes Mellitus
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00758069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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