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History of Changes for Study: NCT03060538
A Phase Ib Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus
Latest version (submitted March 25, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 17, 2017 None (earliest Version on record)
2 May 31, 2017 Arms and Interventions, Study Status, Contacts/Locations, Study Design and Study Identification
3 July 19, 2017 Study Status, Eligibility and Study Description
4 August 25, 2017 Study Status and Contacts/Locations
5 September 20, 2017 Study Status
6 October 20, 2017 Contacts/Locations and Study Status
7 December 12, 2017 Contacts/Locations and Study Status
8 January 8, 2018 Study Status and Contacts/Locations
9 February 13, 2018 Study Status
10 March 15, 2018 Study Status and Contacts/Locations
11 April 12, 2018 Study Status
12 April 27, 2018 Study Status, Eligibility and Study Design
13 July 24, 2018 Contacts/Locations, Study Status, Study Identification, Eligibility, Conditions and Study Description
14 February 28, 2019 Contacts/Locations, Study Status and Study Design
15 March 27, 2019 Study Status and Contacts/Locations
16 April 22, 2019 Study Status
17 May 21, 2019 Study Status
18 June 20, 2019 Study Status
19 July 19, 2019 Study Status
20 August 16, 2019 Study Status
21 September 12, 2019 Study Status
22 October 11, 2019 Study Status
23 November 7, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
24 November 27, 2019 Study Status
25 February 25, 2020 Study Status and Contacts/Locations
26 March 25, 2020 Recruitment Status and Study Status
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Study NCT03060538
Submitted Date:  February 17, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: GC39547
Brief Title: A Phase Ib Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus
Official 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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Recruiting
Study Start: February 6, 2017
Primary Completion: June 2018 [Anticipated]
Study Completion: June 2018 [Anticipated]
First Submitted: February 17, 2017
First Submitted that
Met QC Criteria:
February 17, 2017
First Posted: February 23, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
February 17, 2017
Last Update Posted: February 23, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Genentech, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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 6 weeks), a 12-week treatment period, and a 6-week follow-up period.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetes Mellitus, Type 2
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 1
Masking: Double (Participant, Investigator)
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Multiple Ascending Dose BFKB8488A or Placebo
Participants will be randomized to receive either BFKB8488A or matching placebo. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort.
Drug: BFKB8488A
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Other Names:
  • RO7040551
Placebo
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with Adverse Events (AE)
[ Time Frame: Up to 18 weeks following first dose administration ]

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Secondary Outcome Measures:
1. Serum BFKB8488A Concentration
[ Time Frame: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration) ]

2. Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
[ Time Frame: On multiple days during treatment period and follow-up (up 18 weeks following first dose administration) ]

Participants are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and at least one post-baseline samples if above acceptable limits. The number and percentage of ATA-positive and ATA-negative participants will be summarized by treatment group.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 3 months 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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GC39547 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. Only)
Email: global-roche-genentech-trials@gene.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Alabama
Pinnacle Research Group; Llc, Central
[Not yet recruiting]
Anniston, Alabama, United States, 36207
United States, California
Southern California Research Center, Inc.
[Not yet recruiting]
Coronado, California, United States, 92118
National Research Inst.
[Not yet recruiting]
Los Angeles, California, United States, 90057
Northern California Research
[Not yet recruiting]
Sacramento, California, United States, 95821
United States, Florida
Premier Research Associate, Inc
[Not yet recruiting]
Miami, Florida, United States, 33165
United States, Georgia
Agile Clinical Research Trials
[Not yet recruiting]
Atlanta, Georgia, United States, 30328
United States, New Jersey
Hassman Research Institute
[Not yet recruiting]
Berlin, New Jersey, United States, 08009
United States, North Carolina
Carolina Research Center at Jones Family Practice
[Not yet recruiting]
Shelby, North Carolina, United States, 28150
United States, Tennessee
New Orleans Center for Clinical Research
[Recruiting]
Knoxville, Tennessee, United States, 37920
United States, Texas
Dallas Diabetes & Endocrine Center
[Not yet recruiting]
Dallas, Texas, United States, 75230
Northeast Clinical Research of San Antonio LLC
[Not yet recruiting]
San Antonio, Texas, United States, 78249
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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