Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230786
• Other study ID #: KBP042/CD/003
• Secondary ID: 2017-001061-24
• Status: Completed
• Phase: Phase 2
• Start date: August 23, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: September 2018
• Source: KeyBioscience AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 31, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Daily subcutaneous injection

Locations

Country	Name	City	State
Czechia	Diabetologická a Obezitologická ambulance	Ceské Budejovice
Czechia	Vdoviak Miroslav MUDr. - Interní Ambulance	Karlovy Vary
Czechia	General University Hospital	Prague 2
Czechia	Diabet2 s.r.o	Praha
Czechia	Endokrinologicky Ústav	Praha
Czechia	Interní a Diabetologická ambulance, Clintrial s.r.o	Praha
Czechia	Institute for Clinical and experimental Medicine	Praha 4
Czechia	Interní a Diabetologická ambulance	Uherské Hradište
Denmark	Bioclinica	Aalborg	Jutland
Denmark	Aarhus University Hospital, Endocrinlogy Department	Aarhus	Jutland
Denmark	Bioclinica	Ballerup	Copenhagen
Denmark	Bispebjerg Hospital, Endokrinologisk Afdeling	Bispebjerg	Copenhagen NV
Denmark	Sydvestjysk Sygehus	Esbjerg	Jutland
Denmark	Holbæk Sygehus	Holbæk
Denmark	Bioclinica	Vejle	Jutland
Moldova, Republic of	Rtl Sm Srl	Chisinau
Moldova, Republic of	Rtl Sm Srl/Scr	Chisinau
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk
Poland	Specjalistyczna Praktyka Lekarska Piotr Kubalski	Grudziadz
Poland	Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno	Kraków
Poland	Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer	Lódz
Poland	Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)	Opole
Poland	Centrum Medyczne Hygea	Tychy
Poland	Centrum Medyczne AMED	Warsaw
Romania	Institutului Na?ional de Diabet, Nutri?ie ?i Boli Metabolice "Prof.Dr. N.C. Paulescu"	Bucharest
Romania	S.C Nicodiab S.R.L.	Bucharest
Romania	S.C. Policlinica CCBR S.R.L.	Bucharest
Romania	S.C. Sfinx Medica S.R.L.	Constanta
Romania	S.C. Mediab S.R.L.	Targu Mures
Romania	S.C. Mediab S.R.L.	Târgu-Mures
United Kingdom	St. Pancras	London

Sponsors (2)

Lead Sponsor	Collaborator
KeyBioscience AG	Nordic Bioscience A/S

Countries where clinical trial is conducted

Czechia,  Denmark,  Moldova, Republic of,  Poland,  Romania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in blood HbA1c at 12 weeks versus placebo.		At 12 weeks
Secondary	Change from baseline in body weight at 12 weeks versus placebo.		At 12 weeks
Secondary	Change from baseline in fasting serum glucose at 12 weeks versus placebo		At 12 weeks
Secondary	Change from baseline in fasting serum insulin at 12 weeks versus placebo		At 12 weeks
Secondary	Change from baseline in fasting serum glucagon at 12 weeks versus placebo		At 12 weeks
Secondary	Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo		At 12 weeks