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Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

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ClinicalTrials.gov Identifier: NCT00850239
Recruitment Status : Terminated
First Posted : February 24, 2009
Last Update Posted : August 11, 2010
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Phenomix

Brief Summary:
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: dutogliptin Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Study Start Date : May 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Experimental: 1
dutogliptin/PHX1149T
Drug: dutogliptin
400 mg
Other Name: PHX1149T

Placebo Comparator: 2
Plabeco
Drug: placebo



Primary Outcome Measures :
  1. Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline. [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Demonstrate safety and tolerability of dutogliptin [ Time Frame: 26 weeks ]
  2. • Demonstrate changes in fasting plasma glucose [ Time Frame: 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
  • Age 18 to 85 years, inclusive.
  • Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
  • Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
  • HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)

Exclusion Criteria:

  • Type 1 diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850239


  Show 97 Study Locations
Sponsors and Collaborators
Phenomix
Forest Laboratories

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Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT00850239     History of Changes
Other Study ID Numbers: PHX1149-PROT302
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs