A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Phenomix.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Phenomix
Information provided by:
Phenomix
ClinicalTrials.gov Identifier:
NCT00482950
First received: June 4, 2007
Last updated: June 4, 2009
Last verified: June 2009
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Purpose
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
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Further study details as provided by Phenomix:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482950
Show 26 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482950
Show 26 Study Locations
Sponsors and Collaborators
Phenomix
Investigators
| Study Director: | Hans-Peter Guler, MD | Phenomix Corp. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00482950 History of Changes |
| Other Study ID Numbers: | PHX1149-Prot202 |
| Study First Received: | June 4, 2007 |
| Last Updated: | June 4, 2009 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada India: Ministry of Health Mexico: Minstry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015