Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment phx1149t
Phase phase 2
Sponsor Phenomix
Start date April 2007
End date February 2008
Trial size 400 participants
Trial identifier NCT00482950, PHX1149-Prot202

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
HbA1c
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Phenomix.