E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
A Mixed-Meal Tolerance Test (MMTT) and 7-point glucose profiles will be performed in a sub-group of patients to evaluate the effect of KBP-042 on glucose metabolism in further detail. |
|
E.3 | Principal inclusion criteria |
Before any study-specific procedure, the appropriate written informed consent must be obtained. To be included, subjects must fulfil all he 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 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 randomisation) 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. |
|
E.4 | Principal 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. Positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening. 15. ALT or AST > 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change from baseline in blood HbA1c at 12 weeks versus placebo. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |