Clinical trial NCT03230786: Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
Official title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
KBP-042
Lead sponsor: KeyBioscience AG
Sponsor class: INDUSTRY
Collaborators: name: Nordic Bioscience A/S
First posted: 2017-07-26
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Stable therapy (for at least 90 days prior to randomization) with metformin.
4. Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².
5. The subject is able to understand and comply with protocol requirements.
6. The subject is able and willing to give written informed consent.

Exclusion Criteria:

1. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
2. 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.
3. Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
4. Currently receiving medical treatment for obesity.
5. History of bariatric surgery.
6. Current alcohol abuse.
7. 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.
8. Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days of randomization.
9. Regular use of insulin or insulin analogues.
10. 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.
11. 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.
12. Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.
13. 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.
14. Breast-feeding women.
15. Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
16. 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.
17. Clinically significant ECG abnormalities, as judged by the investigator.

Primary outcomes:
measure: Change from baseline in blood HbA1c at 12 weeks versus placebo.
timeFrame: At 12 weeks
Secondary outcomes:
measure: Change from baseline in body weight at 12 weeks versus placebo.
timeFrame: At 12 weeks
measure: Change from baseline in fasting serum glucose at 12 weeks versus placebo
timeFrame: At 12 weeks
measure: Change from baseline in fasting serum insulin at 12 weeks versus placebo
timeFrame: At 12 weeks
measure: Change from baseline in fasting serum glucagon at 12 weeks versus placebo
timeFrame: At 12 weeks
measure: Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Karlovy Vary
country: Czechia
facility: Vdoviak Miroslav MUDr. - Interní Ambulance
city: Prague 2
country: Czechia
facility: General University Hospital
city: Praha 4
country: Czechia
facility: Institute for Clinical and experimental Medicine
city: Praha
country: Czechia
facility: Interní a Diabetologická ambulance, Clintrial s.r.o
city: Praha
country: Czechia
facility: Endokrinologicky Ústav
city: Praha
country: Czechia
facility: Diabet2 s.r.o
city: Uherské Hradiště
country: Czechia
facility: Interní a Diabetologická ambulance
city: České Budějovice
country: Czechia
facility: Diabetologická a Obezitologická ambulance
city: Bispebjerg
country: Denmark
facility: Bispebjerg Hospital, Endokrinologisk Afdeling
state: Copenhagen NV
city: Ballerup
country: Denmark
facility: Bioclinica
state: Copenhagen
city: Aalborg
country: Denmark
facility: Bioclinica
state: Jutland
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Endocrinlogy Department
state: Jutland
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus
state: Jutland
city: Vejle
country: Denmark
facility: Bioclinica
state: Jutland
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Chisinau
country: Moldova, Republic of
facility: Rtl Sm Srl/Scr
city: Chisinau
country: Moldova, Republic of
facility: Rtl Sm Srl
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-House sp. z o.o.
city: Grudziądz
country: Poland
facility: Specjalistyczna Praktyka Lekarska Piotr Kubalski
city: Kraków
country: Poland
facility: Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno
city: Opole
country: Poland
facility: Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)
city: Tychy
country: Poland
facility: Centrum Medyczne Hygea
city: Warsaw
country: Poland
facility: Centrum Medyczne AMED
city: Łódź
country: Poland
facility: Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
city: Bucharest
country: Romania
facility: S.C. Policlinica CCBR S.R.L.
city: Bucharest
country: Romania
facility: Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"
city: Bucharest
country: Romania
facility: S.C Nicodiab S.R.L.
city: Constanţa
country: Romania
facility: S.C. Sfinx Medica S.R.L.
city: Targu Mures
country: Romania
facility: S.C. Mediab S.R.L.
city: Târgu-Mureş
country: Romania
facility: S.C. Mediab S.R.L.
city: London
country: United Kingdom
facility: St. Pancras
Study officials:
References: