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Completed

NCT Number: NCT01665352

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 18, Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTP054

Drug

Administered orally once daily for 12 weeks.

Placebo

Drug

Administered orally once daily for 12 weeks.

Primary outcomes

  1. Change from baseline in HbA1c (%) as compared to placebo

    Time frame: Day 1 to Day 84

Secondary outcomes

  1. Change from baseline in fasting plasma glucose (mg/dL)

    Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84

  2. Subject achievement of HbA1c <7%

    Time frame: Day 84

  3. Change from baseline in body weight

    Time frame: Day 1, Day 14, Day 28, Day 56 and Day 84

  4. Subject achievement of body weight loss ≥ 2%

    Time frame: Day 1 and Day 84

Sponsors and collaborators

Lead sponsor

vTv Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 15, 2012
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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