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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665352
Enrollment
186
Registered
2012-08-15
Start date
2012-08-31
Completion date
2013-05-31
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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.

Interventions

DRUGTTP054

Administered orally once daily for 12 weeks.

DRUGPlacebo

Administered orally once daily for 12 weeks.

Sponsors

vTv Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1c (%) as compared to placeboDay 1 to Day 84

Secondary

MeasureTime frame
Change from baseline in fasting plasma glucose (mg/dL)Day 1, Day 14, Day 28, Day 56 and Day 84
Subject achievement of HbA1c <7%Day 84
Change from baseline in body weightDay 1, Day 14, Day 28, Day 56 and Day 84
Subject achievement of body weight loss ≥ 2%Day 1 and Day 84

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026