Type 2 Diabetes Mellitus MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: KBP-042
Product Code: KBP-042
Pharmaceutical Form: Solution for injection
INN or Proposed INN: KBP-042
Current Sponsor cod
Sponsors
KeyBioscience AG
Eligibility
Sex/Gender
All
Inclusion 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 condom from enrolment up to at least 3 months after the study end. 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: 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 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities. 16. Clinically significant ECG abnormalities, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; 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. ;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
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: 12 weeks. | — |
Countries
Czech Republic, Denmark, Poland, Romania, United Kingdom
Contacts
Public ContactRegulatory Affairs and Safety Dpt.
Nordic Bioscience Clinical Development
Outcome results
None listed