A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Phenomix.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Phenomix
ClinicalTrials.gov Identifier:
NCT00482950
First Posted: June 6, 2007
Last Update Posted: June 8, 2009
Information provided by:
Phenomix
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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 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 |
Further study details as provided by Phenomix:
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
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
Show 26 Study Locations
Sponsors and Collaborators
Phenomix
Investigators
| Study Director: | Hans-Peter Guler, MD | Phenomix Corp. |
More Information
| ClinicalTrials.gov Identifier: | NCT00482950 History of Changes |
| Other Study ID Numbers: |
PHX1149-Prot202 |
| First Submitted: | June 4, 2007 |
| First Posted: | June 6, 2007 |
| 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 |