Clinical Trial Details

NCT ID: NCT03060538
Date Last Changed: September 20, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating BFKB8488A and Placebo for the treatment of Diabetes Mellitus, Type 2

Research Study Title

A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus

Purpose

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending−dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus. A maximum of approximately 140 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.

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Recruitment Details

Phase
1
Gender
All
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Genentech, Inc.
Duration
15 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 75 Years

Inclusion Criteria:

  • Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2

  • A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening

  • Current stable treatment (at least 3 months) for diabetes

  • Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%

  • For women of childbearing potential, agreement to remain abstinent or use reliable contraception during treatment period and for at least 42 days after last dose of study drug

  • For men, agreement to remain abstinent or use reliable contraception and agree to refrain from donating sperm

Exclusion Criteria:

  • Pregnant, lactating, or intending to become pregnant within 42 days after the last dose of study drug is administered

  • Suspected or confirmed diagnosis of Type 1 diabetes

  • Significant cardiac disease

  • Any psychiatric illness that increases the risk of participation in the study

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions, or severe systemic bacterial, fungal, or parasitic infections

  • Poor peripheral venous access

  • Received blood products within 2 months before dosing

  • Donation or loss of blood within 30-56 days prior to study drug administration

  • Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody

  • Liver enzymes greater than acceptable limits

  • History of eating disorders or surgical procedures for weight loss

  • Active participation in a structured weight loss or dietary program

  • Treatment with investigational therapy or exposure to any biological therapy

  • Illicit drug use, marijuana use, or alcohol abuse

  • Current use of more than one pack of cigarettes a day or equivalent nicotine-containing products

  • Any serious medical condition or abnormality in clinical laboratory tests

Site Locations (14)

Country State City Zip Facility and Contact
United States Alabama Anniston 36207 Pinnacle Research Group; Llc, Central
United States California Coronado 92118 Southern California Research Center, Inc.
United States California Los Angeles 90057 National Research Inst.
United States California Sacramento 95821 Northern California Research
United States California Stanford 94305 Stanford Health Care
United States California Tustin 92780 Diabetes Research Center
United States Florida Miami 33165 Premier Research Associate, Inc
United States Georgia Atlanta 30328 Agile Clinical Research Trials
United States New Jersey Berlin 08009 Hassman Research Institute
United States North Carolina Shelby 28150 Carolina Research Center at Jones Family Practice
United States Tennessee Knoxville 37920 New Orleans Center for Clinical Research
United States Texas Dallas 75230 Dallas Diabetes & Endocrine Center
United States Texas San Antonio 78249 Northeast Clinical Research of San Antonio LLC
Canada Quebec Montreal H3X 2H9 inVentiv Health Clinical

Contact

Reference Study ID Number: GC39547 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. Only)
E-mail:

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