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

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2017-001061-24-PL
• Date of registration: 28/08/2017
• Prospective Registration: Yes
• Primary sponsor: KeyBioscience AG
• Public title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients with Type 2 Diabetes
• Scientific title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients with Type 2 Diabetes
• Date of first enrolment: 13/10/2017
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001061-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Regulatory Affairs and Safety Dpt.
• Affiliation: Nordic Bioscience Clinical Development

• Name: Regulatory Affairs and Safety Dpt.
• Affiliation: Nordic Bioscience Clinical Development

Key inclusion & exclusion criteria

Inclusion criteria:
Before any study-specific procedure, the appropriate written informed consent must be obtained.
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 to use the 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
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, GLP-1 analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
8. Use of thiazolidinediones (glithazones) 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 or AST > 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: KBP-042
Product Code: KBP-042
Pharmaceutical Form: Solution for injection
INN or Proposed INN: KBP-042
Current Sponsor code: KBP-042
Other descriptive name: KBP-042
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The main objective of the trial is to evaluate the efficacy of three months of KBP-042 in Type 2 diabetic patients, in terms of glycaemic control.

Primary end point(s): Change from baseline in blood HbA1c at 12 weeks versus placebo.

Timepoint(s) of evaluation of this end point: 12 weeks.

Secondary Objective: Secondary objectives include evaluations of safety and measures of glucose metabolism through the:
The change from baseline in body weight versus placebo evaluated over 12 weeks.
The change from baseline in fasting serum glucose versus placebo evaluated over 12 weeks.
The change from baseline in fasting serum insulin versus placebo evaluated over 12 weeks.
The change from baseline in fasting serum glucagon versus placebo evaluated over 12 weeks.
Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks.

Secondary end point(s): Change from baseline in body weight at 12 weeks versus placebo.
Change from baseline in fasting serum glucose at 12 weeks versus placebo.
Change from baseline in fasting serum insulin at 12 weeks versus placebo.
Change from baseline in fasting serum glucagon at 12 weeks versus placebo.
Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo

Secondary ID(s)

KBP042/CD/003

2017-001061-24-DK

Source(s) of Monetary Support

KeyBioscience AG