A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

Part of paid clinical trials in Huntington Park, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT04153929
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 456906 — DRUG
    Solution for Injection
  • Placebo — DRUG
    Solution for Injection
  • Semaglutide — DRUG
    Solution for Injection

Study Details

This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight. Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes. During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.

Key Dates

Start date
Apr 30, 2020
Status verified
Nov 2022
Primary completion
Oct 8, 2021
Completion
Nov 4, 2021

Study Design

Enrollment
413 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BI 456906 0.3 mg
  • Experimental: BI 456906 0.9 mg
  • Experimental: BI 456906 1.8 mg
  • Experimental: BI 456906 2.7 mg
  • Experimental: BI 456906 1.2 twice weekly (2.4) mg
  • Experimental: BI 456906 1.8 twice weekly (3.6) mg
  • Active Comparator: Semaglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Absolute Change in HbA1c From Baseline to 16 Weeks [ Time Frame: At baseline and at Week 17 (16 weeks after treatment start). ]

Locations (31)

FacilityCityStateZIPSite coordinators
National Research InstituteHuntington ParkCalifornia90255-
National Research InstituteLos AngelesCalifornia90057-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Indago Research and Health CenterHialeahFlorida33012-
Meridien ResearchLakelandFlorida33803-
San Marcus Research Clinic, Inc.MiamiFlorida33014-
Renstar Medical ResearchOcalaFlorida34470-
Sensible Healthcare, LLCOcoeeFlorida34761-
Meridien ResearchSt. PetersburgFlorida33709-
In-Quest Medical Research, LLCSuwaneeGeorgia30024-
Solaris Clinical ResearchMeridianIdaho83646-
DuPage Medical Group, LtdLombardIllinois60148-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
ActivMed Practices & ResearchMethuenMassachusetts01844-
StudyMetrix Research, LLCCity of Saint PetersMissouri63303-
Mercury Street MedicalButteMontana59701-
Palm Research CenterLas VegasNevada89148-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
PMG Research of Hickory, LLCHickoryNorth Carolina28602-
Lucas Research, Inc.Morehead CityNorth Carolina28557-
PMG Research of Raleigh, LLCRaleighNorth Carolina27609-
PMG Research of Piedmont HealthcareStatesvilleNorth Carolina28625-
PMG Research of Wilmington, LLCWilmingtonNorth Carolina28401-
PMG Research of Winston-SalemWinston-SalemNorth Carolina27103-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Lillestol Research, LLCFargoNorth Dakota58104-
Heritage Valley Medical GroupBeaverPennsylvania15009-
PMG Research of KnoxvilleKnoxvilleTennessee37938-
Dallas Diabetes and Endocrine CenterDallasTexas75230-
Clinical Trials of Texas, LLCSan AntonioTexas78229-
Javara ResearchSugar LandTexas77478-

Find similar trials in Huntington Park, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Research Institute· Huntington Park, CANational Research Institute· Los Angeles, CAValley Clinical Trials, Inc.· Northridge, CAIndago Research and Health Center· Hialeah, FLMeridien Research· Lakeland, FLSan Marcus Research Clinic, Inc.· Miami, FL

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