A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
This study is currently recruiting participants.
Verified November 2012 by TransTech Pharma
Sponsor:
TransTech Pharma
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01665352
First received: August 13, 2012
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: TTP054 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin |
Resource links provided by NLM:
Further study details as provided by TransTech Pharma:
Primary Outcome Measures:
- Change from baseline in HbA1c (%) as compared to placebo [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
- Subject achievement of HbA1c <7% [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
- Change from baseline in body weight [ Time Frame: Day 1, Day 14, Day 28, Day 56 and Day 84 ] [ Designated as safety issue: No ]
- Subject achievement of body weight loss ≥ 2% [ Time Frame: Day 1 and Day 84 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 175 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TTP054 400 mg |
Drug: TTP054
Administered orally once daily for 12 weeks.
|
| Experimental: TTP054 200 mg |
Drug: TTP054
Administered orally once daily for 12 weeks.
|
| Experimental: TTP054 800 mg |
Drug: TTP054
Administered orally once daily for 12 weeks.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Administered orally once daily for 12 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus
- On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent
- HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%
Exclusion Criteria:
- History or evidence of significant diabetic complications
- History of heart attack, stroke or congestive heart failure
- Severe, uncontrolled hypertension
- Frequent hypoglycemia
- Women of child-bearing potential
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665352
Contacts
| Contact: Stephanie Gustavson, Ph.D. | ClinicalTrials@TTPharma.com |
Locations
| United States, California | |
| Site 18 | Recruiting |
| Chula Vista, California, United States, 91911 | |
| Site 1 | Recruiting |
| Los Angeles, California, United States, 90057 | |
| United States, Colorado | |
| Site 13 | Recruiting |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| Site 4 | Recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Site 5 | Recruiting |
| Port Orange, Florida, United States, 32127 | |
| United States, Hawaii | |
| Site 3 | Recruiting |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Indiana | |
| Site 17 | Recruiting |
| Indianapolis, Indiana, United States, 46254 | |
| United States, Kentucky | |
| Site 7 | Recruiting |
| Louisville, Kentucky, United States, 40213 | |
| United States, Maine | |
| Site 8 | Recruiting |
| Auburn, Maine, United States, 04210 | |
| United States, Nevada | |
| Site 9 | Recruiting |
| Las Vegas, Nevada, United States, 89101 | |
| United States, New Jersey | |
| Site 26 | Recruiting |
| Trenton, New Jersey, United States, 08611 | |
| United States, New York | |
| Site 12 | Recruiting |
| Rochester, New York, United States, 14609 | |
| United States, Ohio | |
| Site 14 | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| United States, South Carolina | |
| Site 6 | Recruiting |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Texas | |
| Site 16 | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Site 10 | Recruiting |
| Houston, Texas, United States, 77072 | |
| Site 2 | Recruiting |
| Houston, Texas, United States, 77074 | |
| Site 11 | Recruiting |
| Katy, Texas, United States, 77450 | |
| United States, Virginia | |
| Site 15 | Recruiting |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
TransTech Pharma
Investigators
| Study Director: | Stephanie Gustavson, Ph.D. | TransTech Pharma, Inc. |
More Information
No publications provided
| Responsible Party: | TransTech Pharma |
| ClinicalTrials.gov Identifier: | NCT01665352 History of Changes |
| Other Study ID Numbers: | TTP054-201 |
| Study First Received: | August 13, 2012 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013