Phase 2 Completed N=242 Randomized Double-blind Treatment

Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

Glucose Intolerance

Source: ClinicalTrials.gov NCT01405911 ↗

Enrolled (actual)

242

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcomePrimary: Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8 — -2.42; -9.52; -11.49 Percent change — p=<0.001

Summary

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8	-2.42; -9.52; -11.49	<0.001 sig
PRIMARY Percentage of Participants Who Experienced One or More Adverse Events (AEs)	30.9; 34.1; 41.0	—
PRIMARY Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)	0.0; 0.0; 0.0	—
SECONDARY Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7	-3.68; -21.38; -20.09	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Impaired glucose tolerance
On diet/exercise therapy
Unlikely to conceive
Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Exclusion Criteria

History of diabetes mellitus
Disease or condition of clear or likely glucose tolerance disorder
Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405911). 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.