A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00482950
• Other study ID #: PHX1149-Prot202
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 4, 2007
• Last updated: June 4, 2009
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2009
• Source: Phenomix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIndia: Ministry of HealthMexico: Minstry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Key Entry Criteria:

• Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.

• Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.

• Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).

• Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3%
• 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is = 10.5%. For Canada the upper limit will be 10.0%

• No Type 1 diabetes mellitus or marked diabetic long-term complications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PHX1149T

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phenomix

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		12 weeks