Clinical trial NCT00482950: A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
First posted: 2007-06-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Kissimmee
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Bloomington
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Trenton
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Westminster
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Multiple Cities
country: Argentina
city: Mutiple Cities
country: Canada
city: Mutiple Cities
country: India
city: Mutiple Cities
country: Mexico
Study officials:
affiliation: Phenomix Corp.
name: Hans-Peter Guler, MD
role: STUDY_DIRECTOR
References: