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

NCT ID: NCT03230786

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2018-07-31

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo QD for 12 weeks as add-on to metformin

Group Type: PLACEBO_COMPARATOR

Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Intervention Type: DRUG

Daily subcutaneous injection

15µg KBP-042 QD

Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin

Group Type: EXPERIMENTAL

Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Intervention Type: DRUG

Daily subcutaneous injection

30µg KBP-042 QD

Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin

Group Type: EXPERIMENTAL

Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Intervention Type: DRUG

Daily subcutaneous injection

50µg KBP-042 QD

Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin

Group Type: EXPERIMENTAL

Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Intervention Type: DRUG

Daily subcutaneous injection

Interventions

Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Daily subcutaneous injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordic Bioscience A/S

INDUSTRY

Sponsor Role: collaborator

KeyBioscience AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Diabetologická a Obezitologická ambulance

České Budějovice, , Czechia

Vdoviak Miroslav MUDr. - Interní Ambulance

Karlovy Vary, , Czechia

Interní a Diabetologická ambulance, Clintrial s.r.o

Prague, , Czechia

Endokrinologicky Ústav

Prague, , Czechia

General University Hospital

Prague, , Czechia

Institute for Clinical and experimental Medicine

Prague, , Czechia

Diabet2 s.r.o

Prague, , Czechia

Interní a Diabetologická ambulance

Uherské Hradiště, , Czechia

Bispebjerg Hospital, Endokrinologisk Afdeling

Bispebjerg, Copenhagen NV, Denmark

Bioclinica

Ballerup Municipality, Copenhagen, Denmark

Bioclinica

Aalborg, Jutland, Denmark

Aarhus University Hospital, Endocrinlogy Department

Aarhus, Jutland, Denmark

Sydvestjysk Sygehus

Esbjerg, Jutland, Denmark

Bioclinica

Vejle, Jutland, Denmark

Holbæk Sygehus

Holbæk, , Denmark

Rtl Sm Srl/Scr

Chisinau, , Moldova

Rtl Sm Srl

Chisinau, , Moldova

Centrum Badań Klinicznych PI-House sp. z o.o.

Gdansk, , Poland

Specjalistyczna Praktyka Lekarska Piotr Kubalski

Grudziądz, , Poland

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno

Krakow, , Poland

Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer

Lodz, , Poland

Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)

Opole, , Poland

Centrum Medyczne Hygea

Tychy, , Poland

Centrum Medyczne AMED

Warsaw, , Poland

S.C. Policlinica CCBR S.R.L.

Bucharest, , Romania

Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"

Bucharest, , Romania

S.C Nicodiab S.R.L.

Bucharest, , Romania

S.C. Sfinx Medica S.R.L.

Constanța, , Romania

S.C. Mediab S.R.L.

Târgu Mureş, , Romania

St. Pancras

London, , United Kingdom

Countries

Czechia; Denmark; Moldova; Poland; Romania; United Kingdom

Other Identifiers

2017-001061-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KBP042/CD/003

Identifier Type: -

Identifier Source: org_study_id