MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00289848

First received: February 7, 2006

Last updated: March 18, 2010

Last verified: March 2010

Results First Received: March 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: sitagliptin phosphate Drug: Comparator: placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First Patient In: 27-Apr-2006; Last Patient Last Visit: 30-Mar-2007; Twenty-eight medical clinics (9 in China, 9 in India, and 10 in Korea).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients not on an antihyperglycemic agent (AHA) or on oral single AHA or low dose dual combination therapy could participate. After an up to 6-week diet/exercise (and wash-off period for patients on AHA), patients with hemoglobin A1C 7.5-11% and fasting plasma glucose 130-280 mg/dL entered a 2-week placebo run-in period prior to randomization.

Reporting Groups

	Description
Sitagliptin 100 mg	The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
Placebo	The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.

Participant Flow: Overall Study

	Sitagliptin 100 mg	Placebo
STARTED	352	178
COMPLETED	306	133
NOT COMPLETED	46	45
Adverse Event	6	4
Death	1	0
Lack of Efficacy	20	24
Lost to Follow-up	3	1
Protocol Violation	5	2
Withdrawal by Subject	5	11
Patient Moved	6	2
Open-Label AHA Treatment Requested	0	1

Baseline Characteristics

Reporting Groups

	Description
Sitagliptin 100 mg	The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
Placebo	The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin 100 mg	Placebo	Total
Number of Participants [units: participants]	352	178	530
Age [units: years] Mean ± Standard Deviation	50.9 ± 9.3	50.9 ± 9.3	50.9 ± 9.3
Gender [units: participants]
Female	152	72	224
Male	200	106	306
Race/Ethnicity, Customized [units: participants]
Chinese	163	82	245
Indian	127	63	190
Korean	62	33	95
Fasting Plasma Glucose (FPG) [units: mg/dL] Mean ± Standard Deviation	189.0 ± 44.0	190.2 ± 46.2	189.4 ± 44.7
Hemoglobin A1C (HbA1C; A1C) [units: Percent] Mean ± Standard Deviation	8.74 ± 1.01	8.75 ± 1.06	8.74 ± 1.03