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

vTv Therapeutics

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: TTP054

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665352

TTP054-201

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 4 patient groups, including a placebo group

TTP054 400 mg

Experimental group

Treatment:

Drug: TTP054

TTP054 200 mg

Experimental group

Treatment:

Drug: TTP054

TTP054 800 mg

Experimental group

Treatment:

Drug: TTP054

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo