A Phase 1 interventional study of Daily injection of KBP/placebo for up to 28 days in Type II Diabetes Mellitus, sponsored by KeyBioscience AG. Terminated at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by KeyBioscience AG · Phase 1, Interventional, and Treatment
KeyBioscience is developing KBP-089, a dual activator of both the amylin and calcitonin receptors, for the treatment of type II diabetes mellitus, using a subcutaneous injectable mode of administration.
This is a double-blind, placebo-controlled, randomised, multiple-ascending dose phase I trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of KBP-089 in patients with type 2 diabetes, who are on stable therapy with metformin.
Subjects will receive daily subcutaneous injections in the abdomen over a period of 28 days. The planned maximum doses of KBP-089 to be investigated in the trial are 20 µg in cohort 1, 60 µg in cohort 2, and 150 µg in cohort 3. For cohort 1, the dose is planned to be escalated every 7 ±1 days, and for cohort 2 and cohort 3, every 3 days. Doses may be modified according to individual tolerability, but the dose regimen will not exceed 28 days.
The IMP is administered by daily subcutaneous injections taken in the morning before breakfast.
The trial is performed in Germany and at least 36 patients will be enrolled in the trial. The trial will be randomised 1:1:1 between maximum doses of KBP-089 of 20 µg, 60 µg, 150 µg and placebo. Within each of the three cohorts, 12 patients will be randomised 3:1 to KBP-089 and placebo.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 25 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →KeyBioscience AG is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three cohorts: * Cohort 1: starting dose 5 µg, maximum dose 20 µg, uptitration step 7 days, dose increment 5 µg * Cohort 2: starting dose 7.5 µg, maximum dose 60 µg, uptitration step 3 days, dose increment 7.5 µg * Cohort 3: starting dose 5 µg, maximum dose 120 µg, uptitration step 3 days, dose increment 5, 10, 15 and 20 µg
Drug: Daily injection of KBP/placebo for up to 28 days
For all the cohorts, sentinel dosing for the first two patients will be performed 1:1 in a blinded manner.
Drug: Daily injection of KBP/placebo for up to 28 days
Daily sub-cutaneous injection of KBP-089/Placebo into a lifted skin fold of the abdominal wall.The injection will be administered in the morning before breakfast.
Treatment Emergent Adverse Events (TEAEs).
All TEAEs will be coded using MedDRA and summarized by treatment and dose.
Time frame: Day -1 to day 28
Vital sign - Blood Pressure.
Diastolic and systolic blood pressure (mmHg) are measured after at least 5 min rest in a supine position. Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Time frame: Day -1 to day 28
Vital sign - Pulse (beats per min).
measured after at least 5 min rest in a supine position. Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Time frame: Day -1 to day 28
Vital sign - Body Temperature.
Body temperature, tympanic (in Celcius). Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Time frame: Day -1 to day 28
Vital sign - Respiratory frequency.
Respiratory frequency measured as breaths per min. Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Time frame: Day -1 to day 28
Electrocardiogram (ECG) - PQ interval.
PQ interval (in msec) and any abnormality will be recorded and described in the CRF including the Investigator's assessment of clinical significance ('abnormal, not clinically significant' or 'abnormal, clinically significant').
Time frame: Day -1 to day 28
Electrocardiogram (ECG) - QRS complex.
QRS interval (in msec) and any abnormality will be recorded and described in the CRF including the Investigator's assessment of clinical significance ('abnormal, not clinically significant' or 'abnormal, clinically significant').
Time frame: Day -1 to day 28
Electrocardiogram (ECG) - QT interval.
QT interval (in msec) and any abnormality will be recorded and described in the CRF including the Investigator's assessment of clinical significance ('abnormal, not clinically significant' or 'abnormal, clinically significant').
Time frame: Day -1 to day 28
Safety laboratory parameter - lipids.
Standard Lipid assessments will be summarized by treatment (including dose) using descriptive statistics (number, mean, standard deviation, minimum, median and maximum). (Lipid parameters measured: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Triglycerides).
Time frame: Day -1 to day 28
Safety laboratory parameter - haematology.
Standard Biochemistry assessments will be summarized by treatment (including dose) using descriptive statistics (number, mean, standard deviation, minimum, median and maximum). (Haematology parameters measured: Haematocrit, Haemoglobin, Erythrocytes, Mean corpuscular volume (MCV), Mean corpuscular haemoglobin (MCH), Mean corpuscular haemoglobin concentration (MCHC), Thrombocytes (platelets), Leucocytes, Neutrophile granulocytes (total count and relative), Lymphocytes (total count and relative), Monocytes (total count and relative), Eosinophile granulocytes (total count and relative), Basophile granulocytes (total count and relative))
Time frame: Day -1 to day 28
Safety laboratory parameter - coagulation.
Standard coagulation assessments will be summarized by treatment (including dose) using descriptive statistics (number, mean, standard deviation, minimum, median and maximum). (coagulation parameters measured: International normalised ratio (INR), Activated partial thromboplastin time (APTT)
Time frame: Day -1 to day 28
Safety laboratory parameter - urinalysis.
Standard Biochemistry assessments will be summarized by treatment (including dose) using descriptive statistics (number, mean, standard deviation, minimum, median and maximum). (Urinalysis parameters measured: Protein, Glucose, Erythrocytes, Leucocytes, pH, Ketones)
Time frame: Day -1 to day 28
Pharmacokinetic Evaluation - KBP-089 Area Under Curve.
PK parameter (AUC 0-24) will be derived by non-compartmental analysis of the plasma concentration data for KBP-089
Time frame: Day -1 to day 28
Pharmacokinetic Evaluation - KBP-089 Cmax.
PK parameter (Cmax) will be derived by non-compartmental analysis of the plasma concentration data for KBP-089
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Cmax.
Gastric emptying is measured using paracetamol Cmax at baseline (Day -1), Day 1, and Day 28 for Cohorts 1 and 2 only
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Tmax.
Gastric emptying is measured using paracetamol Tmax at baseline (Day -1), Day 1, and Day 28 for Cohorts 1 and 2 only
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Area Under Curve (AUC).
Gastric emptying is measured using paracetamol AUC at baseline (Day -1), Day 1, and Day 28 for Cohorts 1 and 2 only
Time frame: Day -1 to day 28
Fasting and postprandial glucose concentration.
Fasting and postprandial glucose following OGTT at baseline (Days -1) and Day 28
Time frame: Day -1 to day 28
Fasting and postprandial insulin concentration.
Insulin following OGTT at baseline (Days -1) and Day 28
Time frame: Day -1 to day 28
Fasting and postprandial C-peptide concentration.
Fasting and postprandial C-peptide following OGTT at baseline (Days -1) and Day 28
Time frame: Day -1 to day 28
Fasting and postprandial glucagon concentration.
Fasting and postprandial glucagon following OGTT at baseline (Days -1) and Day 28
Time frame: Day -1 to day 28
Body weight.
Body weight at Day -1 (baseline) and Day 28 (in kg)
Time frame: Day -1 to day 28
N-(1-deoxy)-fructosyl-haemoglobin (HbA1c).
HbA1c at Day -1 (baseline) and Day 28 (in mmol/mol)
Time frame: Day -1 to day 28
Fridericia's corrected QT interval (QTcF).
Fridericia's corrected QT interval (QTcF) at Day 1 and Day 27 (in msec)
Time frame: Day 1 to day 27
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This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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