A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TransTech Pharma
ClinicalTrials.gov Identifier:
NCT01665352
First received: August 13, 2012
Last updated: July 2, 2013
Last verified: July 2013
  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 ]

Enrollment: 186
Study Start Date: August 2012
Study Completion Date: May 2013
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
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: NCT01665352

Locations
United States, California
Site 18
Chula Vista, California, United States, 91911
Site 1
Los Angeles, California, United States, 90057
United States, Colorado
Site 13
Denver, Colorado, United States, 80220
United States, Florida
Site 4
Coral Gables, Florida, United States, 33134
Site 5
Port Orange, Florida, United States, 32127
United States, Hawaii
Site 3
Honolulu, Hawaii, United States, 96814
United States, Indiana
Site 17
Indianapolis, Indiana, United States, 46254
United States, Kentucky
Site 7
Louisville, Kentucky, United States, 40213
United States, Maine
Site 8
Auburn, Maine, United States, 04210
United States, Nevada
Site 9
Las Vegas, Nevada, United States, 89101
United States, New Jersey
Site 26
Trenton, New Jersey, United States, 08611
United States, New York
Site 12
Rochester, New York, United States, 14609
United States, Ohio
Site 14
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Site 6
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Site 16
Dallas, Texas, United States, 75230
Site 10
Houston, Texas, United States, 77072
Site 2
Houston, Texas, United States, 77074
Site 11
Katy, Texas, United States, 77450
United States, Virginia
Site 15
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: July 2, 2013
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 August 26, 2014