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Completed

NCT Number: NCT00690638

Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
  • BMI 25 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 75 years, inclusive

Exclusion criteria

  • Currently on 3 or more oral antidiabetic drugs or insulin.
  • Type 1 diabetes mellitus

Treatment and study plan

PHX1149T

Drug

200 mg

Other names: dutogliptin

Placebo

Drug

Placebo

Primary outcomes

  1. To demonstrate changes in HbA1c

    Time frame: Day 28 to Day 196

Sponsors and collaborators

Lead sponsor

Phenomix

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 4, 2008
Registry last updated
Apr 13, 2010

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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