An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Comparator: sitagliptin 100 mg
Drug: Comparator: placebo
Drug: Comparator: pioglitazone
Drug: Comparator: sitagliptin 200 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00094757
0431-023
2004_045

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Enrollment

521 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion criteria

  • Younger than 18 years of age or older than 75
  • Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

521 participants in 3 patient groups, including a placebo group

Sitagliptin 100 mg
Experimental group
Description:
Sitagliptin 100 mg
Treatment:
Drug: Comparator: sitagliptin 100 mg
Sitagliptin 200 mg
Experimental group
Description:
Sitagliptin 200 mg
Treatment:
Drug: Comparator: sitagliptin 200 mg
Placebo/Pioglitazone
Placebo Comparator group
Description:
Placebo/Pioglitazone
Treatment:
Drug: Comparator: pioglitazone
Drug: Comparator: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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