Type II Diabetes MellitusPhase 1NCT03907202
A Clinical Study to Evaluate the Safety, Tolerability, PK, PD, and Efficacy of KBP-089 in Patients With T2DM
A Phase 1 study of Type II Diabetes Mellitus, run by KeyBioscience AG at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type II Diabetes Mellitus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 17 Apr 2018to 3 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the patient).
- Male or female patient with T2DM.
- Age between 18 and 64 years, both inclusive.
- Body Mass Index (BMI) >= 25.0 kg/m^2.
- HbA1c >= 7 and <=9.5%.
- Stable therapy with metformin ± treatment with a second oral anti-diabetes drug (OAD) belonging to the class of dipeptidyl-peptidase 4 (DPP-4) inhibitors or sulfonylureas for at least 2 months prior to inclusion into the trial or not treated with glucose-lowering medications. Patients who are receiving stable treatment with a second OAD will be asked to discontinue the DPP-4 inhibitor or a sulfonylurea for at least 14 days prior the Initial Inpatient Dosing Visit.
- Considered generally healthy (apart from T2DM) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.
Who cannot join
- Known or suspected hypersensitivity or allergy to paracetamol or related products.
- Prior treatment with a dual amylin and calcitonin receptor agonist (DACRA) or salmon calcitonin.
- Receipt of any medicinal product in clinical development within 30 days or 5 half-lives of the medicinal product (whichever is longer) before randomisation in this trial.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
- Medically unable or unwilling to discontinue current anti-diabetic therapy with DPP-4 inhibitor or sulfonylurea for at least 14 days prior to admission to the research facility (Day -2) and remain off medication until the follow-up visit. Patients taking metformin therapy at entry will continue their metformin at the usual individual dose throughout the trial.
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- Have had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening.
- A positive result in the alcohol and/or urine drug screen at the screening visit.
- Positive to the screening test for Hepatitis Bs antigen (HBsAg) or Hepatitis C antibodies and/or a positive result to the test for human immunodeficiency virus (HIV)-1/2 antibodies or HIV-1 antigen.
- Have had a blood transfusion or severe blood loss within the past 6 months or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or have a hemoglobin value <11 g/dL (males) or <10 g/dL (females), or any other condition known to interfere with HbA1c methodology.
- Blood donation or blood loss of more than 500 mL within the last 3 months or any blood donation within the last month prior to screening.
- Females of childbearing potential.
- Males with pregnant partners.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomised, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KBP-089 in Patients With Type II Diabetes
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.
Read more
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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Daily injection of KBP/placebo for up to 28 days
- Keywords
- Sub-cutaneous injection, Metformin, KBP-089, randomised, placebo-controlled, multiple-ascending dose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily injection of KBP/placebo for up to 28 daysDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| KBP-089 | Active comparator | 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 Receives: Drug: Daily injection of KBP/placebo for up to 28 days |
| Placebo | Placebo comparator | For all the cohorts, sentinel dosing for the first two patients will be performed 1:1 in a blinded manner. Receives: Drug: Daily injection of KBP/placebo for up to 28 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs).
All TEAEs will be coded using MedDRA and summarized by treatment and dose.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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').
Measured: 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').
Measured: 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').
Measured: 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).
Measured: 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))
Measured: 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)
Measured: 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)
Measured: Day -1 to day 28
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day -1 to day 28
Fasting and postprandial glucose concentration.
Fasting and postprandial glucose following OGTT at baseline (Days -1) and Day 28
Measured: Day -1 to day 28
Fasting and postprandial insulin concentration.
Insulin following OGTT at baseline (Days -1) and Day 28
Measured: 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
Measured: Day -1 to day 28
Fasting and postprandial glucagon concentration.
Fasting and postprandial glucagon following OGTT at baseline (Days -1) and Day 28
Measured: Day -1 to day 28
Body weight.
Body weight at Day -1 (baseline) and Day 28 (in kg)
Measured: Day -1 to day 28
N-(1-deoxy)-fructosyl-haemoglobin (HbA1c).
HbA1c at Day -1 (baseline) and Day 28 (in mmol/mol)
Measured: 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)
Measured: Day 1 to day 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start17 Apr 2018
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Why it stopped: The trial was planned to be conducted in 4 cohorts but was terminated after completion of Cohort 2 for strategic reasons due to limited PD effects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, patient-blind, investigator-blind, placebo-controlled, multiple ascending dose study. There will be 3 cohorts in which patients are randomised to receive either treatment with KBP-089 or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- KeyBioscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company, Nordic Bioscience A/S, Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907202
- Sponsor's protocol ID
- KBP089/CD/002
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised, Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KBP-089 in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT03907202
- Acronym / sponsor ID
- KBP089/CD/002
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Sub-cutaneous injection, Metformin, KBP-089, randomised, placebo-controlled, multiple-ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was planned to be conducted in 4 cohorts but was terminated after completion of Cohort 2 for strategic reasons due to limited PD effects.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- KeyBioscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company, Nordic Bioscience A/S, Profil Institut für Stoffwechselforschung GmbH
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, patient-blind, investigator-blind, placebo-controlled, multiple ascending dose study. There will be 3 cohorts in which patients are randomised to receive either treatment with KBP-089 or placebo.
| Arm | Type | Receives |
|---|---|---|
| KBP-089 | Active comparator | Drug: Daily injection of KBP/placebo for up to 28 daysThree 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 |
| Placebo | Placebo comparator | Drug: Daily injection of KBP/placebo for up to 28 daysFor all the cohorts, sentinel dosing for the first two patients will be performed 1:1 in a blinded manner. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the patient).
- Male or female patient with T2DM.
- Age between 18 and 64 years, both inclusive.
- Body Mass Index (BMI) >= 25.0 kg/m^2.
- HbA1c >= 7 and <=9.5%.
Key exclusion criteria (13 listed)
- Known or suspected hypersensitivity or allergy to paracetamol or related products.
- Prior treatment with a dual amylin and calcitonin receptor agonist (DACRA) or salmon calcitonin.
- Receipt of any medicinal product in clinical development within 30 days or 5 half-lives of the medicinal product (whichever is longer) before randomisation in this trial.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily injection of KBP/placebo for up to 28 daysDaily 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. | Drug | KBP-089, Placebo |
Primary outcome
Treatment Emergent Adverse Events (TEAEs).
Time frame: Day -1 to day 28
All TEAEs will be coded using MedDRA and summarized by treatment and dose.
Vital sign - Blood Pressure.
Time frame: Day -1 to day 28
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.
Vital sign - Pulse (beats per min).
Time frame: Day -1 to day 28
measured after at least 5 min rest in a supine position. Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Vital sign - Body Temperature.
Time frame: Day -1 to day 28
Body temperature, tympanic (in Celcius). Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Vital sign - Respiratory frequency.
Time frame: Day -1 to day 28
Respiratory frequency measured as breaths per min. Vital signs will be summarised by descriptive statistics by treatment, dose and timepoint.
Electrocardiogram (ECG) - PQ interval.
Time frame: Day -1 to day 28
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').
Electrocardiogram (ECG) - QRS complex.
Time frame: Day -1 to day 28
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').
Electrocardiogram (ECG) - QT interval.
Time frame: Day -1 to day 28
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').
Safety laboratory parameter - lipids.
Time frame: Day -1 to day 28
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).
Safety laboratory parameter - haematology.
Time frame: Day -1 to day 28
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))
Safety laboratory parameter - coagulation.
Time frame: Day -1 to day 28
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)
Safety laboratory parameter - urinalysis.
Time frame: Day -1 to day 28
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)
12 secondary outcomes
Pharmacokinetic Evaluation - KBP-089 Area Under Curve.
Time frame: Day -1 to day 28
Pharmacokinetic Evaluation - KBP-089 Cmax.
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Cmax.
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Tmax.
Time frame: Day -1 to day 28
Gastric emptying - Paracetamol Area Under Curve (AUC).
Time frame: Day -1 to day 28
Fasting and postprandial glucose concentration.
Time frame: Day -1 to day 28
Fasting and postprandial insulin concentration.
Time frame: Day -1 to day 28
Fasting and postprandial C-peptide concentration.
Time frame: Day -1 to day 28
Fasting and postprandial glucagon concentration.
Time frame: Day -1 to day 28
Body weight.
Time frame: Day -1 to day 28
N-(1-deoxy)-fructosyl-haemoglobin (HbA1c).
Time frame: Day -1 to day 28
Fridericia's corrected QT interval (QTcF).
Time frame: Day 1 to day 27
Results and safety
The study was stopped early (reason given: The trial was planned to be conducted in 4 cohorts but was terminated after completion of Cohort 2 for strategic reasons due to limited PD effects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Type II Diabetes Mellitus, run by KeyBioscience AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was planned to be conducted in 4 cohorts but was terminated after completion of Cohort 2 for strategic reasons due to limited PD effects.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs). (time frame: Day -1 to day 28). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.