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MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00837577
Enrollment
133
Registered
2009-02-05
Start date
2009-02-05
Completion date
2010-08-11
Last updated
2017-05-15

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

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Brief summary

The phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

Interventions

DRUGComparator: Placebo

Placebo to sitagliptin once daily for 12 weeks (double-blind period)

DRUGSitagliptin

Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.

DRUGVoglibose

All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Exclusion criteria

* Patients Have A History Of Type 1 Diabetes Mellitus

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12Baseline and Week 12Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).

Secondary

MeasureTime frameDescription
Change From Baseline in 2-hour Postprandial Glucose at Week 12Baseline and Week 12Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12Baseline and Week 12Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

Participant flow

Participants by arm

ArmCount
Sitagliptin/Sitagliptin
Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
70
Placebo/Sitagliptin
Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
63
Total133

Withdrawals & dropouts

PeriodReasonFG000FG001
Double-blind PeriodClinical Adverse Event10
Double-blind PeriodWithdrawal by Subject10
Open-label PeriodClinical Adverse Event22
Open-label PeriodLaboratory Adverse Event01
Open-label PeriodLack of Efficacy43
Open-label PeriodOther Reason11
Open-label PeriodWithdrawal by Subject12

Baseline characteristics

CharacteristicSitagliptin/SitagliptinTotalPlacebo/Sitagliptin
2-hour Postprandial Glucose217.99 mg/dL
STANDARD_DEVIATION 53.22
213.92 mg/dL
STANDARD_DEVIATION 52.82
209.40 mg/dL
STANDARD_DEVIATION 52.42
Age, Continuous62.34 years
STANDARD_DEVIATION 10.25
60.57 years
STANDARD_DEVIATION 10.15
58.60 years
STANDARD_DEVIATION 9.73
Fasting Plasma Glucose (FPG)152.69 mg/dL
STANDARD_DEVIATION 37.06
152.14 mg/dL
STANDARD_DEVIATION 34.02
151.54 mg/dL
STANDARD_DEVIATION 30.57
Hemoglobin A1c (HbA1c)7.52 Percent
STANDARD_DEVIATION 0.75
7.51 Percent
STANDARD_DEVIATION 0.79
7.50 Percent
STANDARD_DEVIATION 0.84
Region of Enrollment
Japan
70 participants133 participants63 participants
Sex: Female, Male
Female
28 Participants46 Participants18 Participants
Sex: Female, Male
Male
42 Participants87 Participants45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
7 / 705 / 6351 / 133
serious
Total, serious adverse events
0 / 701 / 638 / 133

Outcome results

Primary

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Sitagliptin/SitagliptinChange From Baseline in Hemoglobin A1c (HbA1c) at Week 12-0.76 Percentage of glycosylated hemoglobin95% Confidence Interval 0.42
Placebo/SitagliptinChange From Baseline in Hemoglobin A1c (HbA1c) at Week 120.16 Percentage of glycosylated hemoglobin95% Confidence Interval 0.64
p-value: <0.00195% CI: [-1.09, -0.75]Longitudinal data analysis (LDA)
Secondary

Change From Baseline in 2-hour Postprandial Glucose at Week 12

Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Sitagliptin/SitagliptinChange From Baseline in 2-hour Postprandial Glucose at Week 12-55.3 mg/dL95% Confidence Interval 37.9
Placebo/SitagliptinChange From Baseline in 2-hour Postprandial Glucose at Week 12-4.0 mg/dL95% Confidence Interval 38.7
p-value: <0.00195% CI: [-62.3, -40.2]Longitudinal data analysis (LDA)
Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

Time frame: Baseline and Week 12

Population: Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Sitagliptin/SitagliptinChange From Baseline in Fasting Plasma Glucose (FPG) at Week 12-22.6 mg/dL95% Confidence Interval 27.1
Placebo/SitagliptinChange From Baseline in Fasting Plasma Glucose (FPG) at Week 12-0.1 mg/dL95% Confidence Interval 22.2
p-value: <0.00195% CI: [-30, -15]Longitudinal data analysis (LDA)

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026