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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03230786
• Date of registration: 24/07/2017
• Prospective Registration: Yes
• Primary sponsor: KeyBioscience AG
• Public title: 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: August 23, 2017
• Target sample size: 255
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03230786
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

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

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

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

Primary Outcome(s)

Change from baseline in blood HbA1c at 12 weeks versus placebo. [Time Frame: At 12 weeks]

Secondary Outcome(s)

Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo [Time Frame: At 12 weeks]

Change from baseline in fasting serum glucose at 12 weeks versus placebo [Time Frame: At 12 weeks]

Change from baseline in fasting serum glucagon at 12 weeks versus placebo [Time Frame: At 12 weeks]

Change from baseline in body weight at 12 weeks versus placebo. [Time Frame: At 12 weeks]

Change from baseline in fasting serum insulin at 12 weeks versus placebo [Time Frame: At 12 weeks]

Secondary ID(s)

2017-001061-24

KBP042/CD/003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nordic Bioscience A/S