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Clinical Trial Details

Trial ID: L5030
Source ID: NCT03907202
Associated Drug: Daily Injection Of Kbp/Placebo For Up To 28 Days
Title: A Clinical Study to Evaluate the Safety, Tolerability, PK, PD, and Efficacy of KBP-089 in Patients With T2DM
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: Daily injection of KBP/placebo for up to 28 days
Outcome Measures: Primary: Treatment Emergent Adverse Events (TEAEs)., All TEAEs will be coded using MedDRA and summarized by treatment and dose., 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., 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., 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., 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., 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')., 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')., 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')., 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)., 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)), 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), 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), Day -1 to day 28 | Secondary: 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, 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, 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, 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, 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, Day -1 to day 28|Fasting and postprandial glucose concentration., Fasting and postprandial glucose following OGTT at baseline (Days -1) and Day 28, Day -1 to day 28|Fasting and postprandial insulin concentration., Insulin following OGTT at baseline (Days -1) and Day 28, 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, Day -1 to day 28|Fasting and postprandial glucagon concentration., Fasting and postprandial glucagon following OGTT at baseline (Days -1) and Day 28, Day -1 to day 28|Body weight., Body weight at Day -1 (baseline) and Day 28 (in kg), Day -1 to day 28|N-(1-deoxy)-fructosyl-haemoglobin (HbA1c)., HbA1c at Day -1 (baseline) and Day 28 (in mmol/mol), 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), Day 1 to day 27
Sponsor/Collaborators: Sponsor: KeyBioscience AG | Collaborators: Eli Lilly and Company|Nordic Bioscience A/S|Profil Institut für Stoffwechselforschung GmbH
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-04-17
Completion Date: 2019-12-03
Results First Posted:
Last Update Posted: 2020-09-03
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, D-41460, Germany
URL: https://clinicaltrials.gov/show/NCT03907202