- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230786
Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type 2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of metformin.
The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and United Kingdom
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Karlovy Vary, Czechia, 360 17
- Vdoviak Miroslav MUDr. - Interní Ambulance
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Prague 2, Czechia, 128 00
- General University Hospital
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Praha, Czechia, 100 00
- Interní a Diabetologická ambulance, Clintrial s.r.o
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Praha, Czechia, 113 94
- Endokrinologicky ustav
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Praha, Czechia
- Diabet2 s.r.o
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Praha 4, Czechia, 140 21
- Institute for Clinical and Experimental Medicine
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Uherské Hradiště, Czechia, 68 601
- Interní a Diabetologická ambulance
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České Budějovice, Czechia
- Diabetologicka a obezitologicka ambulance
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Holbæk, Denmark, 4300
- Holbæk Sygehus
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Copenhagen
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Ballerup, Copenhagen, Denmark, 2750
- Bioclinica
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Copenhagen NV
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Bispebjerg, Copenhagen NV, Denmark, 2400
- Bispebjerg Hospital, Endokrinologisk Afdeling
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Jutland
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Aalborg, Jutland, Denmark, 9000
- Bioclinica
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Aarhus, Jutland, Denmark, 8000
- Aarhus University Hospital, Endocrinlogy Department
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Esbjerg, Jutland, Denmark, 6700
- Sydvestjysk Sygehus
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Vejle, Jutland, Denmark, 7100
- Bioclinica
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Chisinau, Moldova, Republic of, MD2025
- Rtl Sm Srl/Scr
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Chisinau, Moldova, Republic of, MD2025
- Rtl Sm Srl
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Gdańsk, Poland, 80-546
- Centrum Badań Klinicznych PI-House sp. z o.o.
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Grudziądz, Poland, 86-302
- Specjalistyczna Praktyka Lekarska Piotr Kubalski
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Kraków, Poland, 31-261
- Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno
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Opole, Poland, 45-367
- Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)
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Tychy, Poland, 43-100
- Centrum Medyczne Hygea
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Warsaw, Poland, 01-518
- Centrum Medyczne AMED
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Łódź, Poland, 90-074
- Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
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Bucharest, Romania, 030463
- S.C. Policlinica CCBR S.R.L.
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Bucharest, Romania
- Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"
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Bucharest, Romania
- S.C Nicodiab S.R.L.
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Constanţa, Romania, 900412
- S.C. Sfinx Medica S.R.L.
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Targu Mures, Romania
- S.C. Mediab S.R.L.
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Târgu-Mureş, Romania
- S.C. Mediab S.R.L.
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London, United Kingdom, WC1X 8QD
- St. Pancras
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects, 18-75 years of age, both inclusive, at the time of the first screening visit. Women must be either using adequate, highly effective methods of contraception, be post-menopausal or be considered sterile due to tubal ligation or other surgical procedures at the time of randomization. Sexually active men with a female partner of childbearing potential must agree in the use of highly effective method of contraception by the female partner throughout the trial period.
- Subjects with type 2 diabetes mellitus diagnosis whose HbA1c levels are ≥7.0% and ≤10.0% (53 mmol/mol to 86 mmol/mol, respectively) at screening.
- Stable therapy (for at least 90 days prior to randomization) with metformin.
- Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².
- The subject is able to understand and comply with protocol requirements.
- The subject is able and willing to give written informed consent.
Exclusion Criteria:
- Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
- Past or present significant co-morbidity (other than type 2 diabetes mellitus) including, but not limited to: Active liver disease (other than asymptomatic non-alcoholic fatty liver disease), significant renal disease (including creatinine clearance < 45 ml/min by the Modification of Diet in Renal Disease (MDRD) method, congestive heart failure (NYHA class III or IV), myocardial infarction within the past 12 months, unstable angina pectoris.
- Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
- Currently receiving medical treatment for obesity.
- History of bariatric surgery.
- Current alcohol abuse.
- Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors, DPP4-inhibitors (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1) analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
- Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days of randomization.
- Regular use of insulin or insulin analogues.
- History or presence of sensitivity or allergy to the study drug or drugs, to their components, or drugs of these classes or a history of drug or other allergy that contraindicates participation.
- History of sarcoma or other malignancy within the past five years, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
- Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to randomization or during the treatment phase of the trial.
- Breast-feeding women.
- Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
- ALT (alanine transaminase) or AST (aspartat transaminase) > 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities.
- Clinically significant ECG abnormalities, as judged by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo QD for 12 weeks as add-on to metformin
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Daily subcutaneous injection
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Experimental: 15µg KBP-042 QD
Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin
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Daily subcutaneous injection
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Experimental: 30µg KBP-042 QD
Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin
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Daily subcutaneous injection
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Experimental: 50µg KBP-042 QD
Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin
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Daily subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in blood HbA1c at 12 weeks versus placebo.
Time Frame: At 12 weeks
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At 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in body weight at 12 weeks versus placebo.
Time Frame: At 12 weeks
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At 12 weeks
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Change from baseline in fasting serum glucose at 12 weeks versus placebo
Time Frame: At 12 weeks
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At 12 weeks
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Change from baseline in fasting serum insulin at 12 weeks versus placebo
Time Frame: At 12 weeks
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At 12 weeks
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Change from baseline in fasting serum glucagon at 12 weeks versus placebo
Time Frame: At 12 weeks
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At 12 weeks
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Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo
Time Frame: At 12 weeks
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At 12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBP042/CD/003
- 2017-001061-24 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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