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

August 13, 2012
July 2, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
Change from baseline in HbA1c (%) as compared to placebo [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01665352 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: TTP054
    Administered orally once daily for 12 weeks.
  • Drug: Placebo
    Administered orally once daily for 12 weeks.
  • Experimental: TTP054 400 mg
    Intervention: Drug: TTP054
  • Experimental: TTP054 200 mg
    Intervention: Drug: TTP054
  • Experimental: TTP054 800 mg
    Intervention: Drug: TTP054
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01665352
TTP054-201
No
TransTech Pharma
TransTech Pharma
Not Provided
Study Director: Stephanie Gustavson, Ph.D. TransTech Pharma, Inc.
TransTech Pharma
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP