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OpenTrials
Completed

NCT Number: NCT00832390

Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

After 24 weeks of treatment evaluate the efficacy and security.

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients Being Treated With Metformin
  • Patients With Hba1c Between 6.5 % And 12.0%.
  • Type 2 DM

Treatment and study plan

sitagliptin phosphate

Drug

Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

Other names: MK0431

Primary outcomes

  1. Change From Baseline in A1C at Week 24

    Time frame: Baseline and 24 Weeks

    Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 30, 2009
Registry last updated
May 30, 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.

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