Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-01

Study Completion Date

2008-07-25

Brief Summary

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A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Drug

Group Type EXPERIMENTAL

sitagliptin phosphate

Intervention Type DRUG

(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period

2

Active comparator

Group Type ACTIVE_COMPARATOR

Comparator: metformin hydrochloride

Intervention Type DRUG

(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

Interventions

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sitagliptin phosphate

(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period

Intervention Type DRUG

Comparator: metformin hydrochloride

(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

Intervention Type DRUG

Other Intervention Names

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MK0431

Eligibility Criteria

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Inclusion Criteria

* Patient has type 2 diabetes mellitus (T2DM)
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

Exclusion Criteria

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No