A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00482950 |
Recruitment Status
: Unknown
Verified June 2009 by Phenomix.
Recruitment status was: Active, not recruiting
First Posted
: June 6, 2007
Last Update Posted
: June 8, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: PHX1149T | Phase 2 |
Phenomix has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 Start Date : | April 2007 |
Estimated Study Completion Date : | February 2008 |

- HbA1c [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00482950

Study Director: | Hans-Peter Guler, MD | Phenomix Corp. |
ClinicalTrials.gov Identifier: | NCT00482950 History of Changes |
Other Study ID Numbers: |
PHX1149-Prot202 |
First Posted: | June 6, 2007 Key Record Dates |
Last Update Posted: | June 8, 2009 |
Last Verified: | June 2009 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |