Skip to main content
OpenTrials
Completed

NCT Number: NCT00449930

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria:

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

General 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

Treatment and study plan

sitagliptin phosphate

Drug

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

Other names: MK0431

Comparator: metformin hydrochloride

Drug

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

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24

    Time frame: Baseline and 24 weeks

    HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary outcomes

  1. Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea

    Time frame: Baseline to Week 24

  2. Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea

    Time frame: Baseline to Week 24

  3. Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain

    Time frame: Baseline to Week 24

  4. Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting

    Time frame: Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2007
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.