Type 2 Diabetes MellitusPhase 2NCT03230786
Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
A Phase 2 study of Type 2 Diabetes Mellitus, run by KeyBioscience AG at 30 sites in 6 countries.
Trial summary
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type 2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of metformin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 23 Aug 2017to 31 Jul 2018
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 in the use of highly effective method of contraception by the female partner throughout the trial period.
- 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.
- Stable therapy (for at least 90 days prior to randomization) with metformin.
- Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².
- The subject is able to understand and comply with protocol requirements.
- The subject is able and willing to give written informed consent.
Who cannot join
- Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
- 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.
- Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
- Currently receiving medical treatment for obesity.
- History of bariatric surgery.
- Current alcohol abuse.
Show all 17Show fewer
- Current medical non-metformin anti-diabetic therapy, including SGLT2-inhibitors, DPP4-inhibitors (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1) analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
- Use of thiazolidinediones (glitazones) lasting for more than one month within 90 days of randomization.
- Regular use of insulin or insulin analogues.
- 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.
- 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.
- Participation in a study trial with any investigational new drug (new chemical entity) within 90 days prior to the start of the study.
- 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.
- Breast-feeding women.
- Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
- ALT (alanine transaminase) or AST (aspartat transaminase) > 2.5 times the upper limit of normal at screening or other clinically significant liver function test abnormalities.
- Clinically significant ECG abnormalities, as judged by the investigator.
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Czechia8 sites
Diabetologická a Obezitologická ambulance
České Budějovice
Vdoviak Miroslav MUDr. - Interní Ambulance
Karlovy Vary, 360 17
Interní a Diabetologická ambulance, Clintrial s.r.o
Prague, 100 00
Endokrinologicky Ústav
Prague, 113 94
General University Hospital
Prague, 128 00
Institute for Clinical and experimental Medicine
Prague, 140 21
Diabet2 s.r.o
Prague
Interní a Diabetologická ambulance
Uherské Hradiště, 68 601
Denmark7 sites
Bioclinica
Aalborg, Jutland, 9000
Aarhus University Hospital, Endocrinlogy Department
Aarhus, Jutland, 8000
Bioclinica
Ballerup Municipality, Copenhagen, 2750
Bispebjerg Hospital, Endokrinologisk Afdeling
Bispebjerg, Copenhagen NV, 2400
Sydvestjysk Sygehus
Esbjerg, Jutland, 6700
Holbæk Sygehus
Holbæk, 4300
Bioclinica
Vejle, Jutland, 7100
Poland7 sites
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
Specjalistyczna Praktyka Lekarska Piotr Kubalski
Grudziądz, 86-302
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno
Krakow, 31-261
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Lodz, 90-074
Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)
Opole, 45-367
Centrum Medyczne Hygea
Tychy, 43-100
Centrum Medyczne AMED
Warsaw, 01-518
Romania5 sites
S.C. Policlinica CCBR S.R.L.
Bucharest, 030463
Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"
Bucharest
S.C Nicodiab S.R.L.
Bucharest
S.C. Sfinx Medica S.R.L.
Constanța, 900412
S.C. Mediab S.R.L.
Târgu Mureş
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type 2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of metformin.
The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and United Kingdom
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Daily injection of KBP/placebo for 12 weeks as add-on to metformin
- Keywords
- Type 2 Diabetes Mellitus, KBP-042
- 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 12 weeks as add-on to metforminDrug
Daily subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo QD for 12 weeks as add-on to metformin Receives: Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin |
| 15µg KBP-042 QD | Experimental | Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin Receives: Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin |
| 30µg KBP-042 QD | Experimental | Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin Receives: Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin |
| 50µg KBP-042 QD | Experimental | Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin Receives: Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood HbA1c at 12 weeks versus placebo.
Measured: At 12 weeks
Secondary outcomes (5)
Change from baseline in body weight at 12 weeks versus placebo.
Measured: At 12 weeks
Change from baseline in fasting serum glucose at 12 weeks versus placebo
Measured: At 12 weeks
Change from baseline in fasting serum insulin at 12 weeks versus placebo
Measured: At 12 weeks
Change from baseline in fasting serum glucagon at 12 weeks versus placebo
Measured: At 12 weeks
Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start23 Aug 2017
- Primary completion9 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- KeyBioscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230786
- Sponsor's protocol ID
- KBP042/CD/003
- Other IDs
- 2017-001061-24, 2017
- Status last verified
- Sep 2018
- First submitted
- 24 Jul 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03230786
- Acronym / sponsor ID
- KBP042/CD/003
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, KBP-042
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- KeyBioscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Nordic Bioscience A/S
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 26 Jul 2017 (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.
This is a multicentre, randomized, double-blind, placebo-controlled, parallel-group Phase II trial of twelve weeks of KBP-042 administered as daily s.c. injections in subjects with Type 2 Diabetes Mellitus with inadequate glycaemic control while treated with a stable dose of metformin.
The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and United Kingdom
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metforminPlacebo QD for 12 weeks as add-on to metformin |
| 15µg KBP-042 QD | Experimental | Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metforminUp to 15µg KBP-042 QD for 12 weeks as add-on to metformin |
| 30µg KBP-042 QD | Experimental | Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metforminUp to 30µg KBP-042 QD for 12 weeks as add-on to metformin |
| 50µg KBP-042 QD | Experimental | Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metforminUp to 50µg KBP-042 QD for 12 weeks as add-on to metformin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 in the use of highly effective method of contraception by the female partner throughout the trial period.
- 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.
- Stable therapy (for at least 90 days prior to randomization) with metformin.
- Body mass index (BMI) ≥ 25.0 kg/m², and ≤ 45.0 kg/m².
- The subject is able to understand and comply with protocol requirements.
Key exclusion criteria (17 listed)
- Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination.
- 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.
- Prior treatment in clinical trials with dual amylin and calcitonin receptor agonists (DACRAs).
- Currently receiving medical treatment for obesity.
- History of bariatric surgery.
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 12 weeks as add-on to metforminDaily subcutaneous injection | Drug | 15µg KBP-042 QD, 30µg KBP-042 QD, 50µg KBP-042 QD, Placebo |
Primary outcome
Change from baseline in blood HbA1c at 12 weeks versus placebo.
Time frame: At 12 weeks
5 secondary outcomes
Change from baseline in body weight at 12 weeks versus placebo.
Time frame: At 12 weeks
Change from baseline in fasting serum glucose at 12 weeks versus placebo
Time frame: At 12 weeks
Change from baseline in fasting serum insulin at 12 weeks versus placebo
Time frame: At 12 weeks
Change from baseline in fasting serum glucagon at 12 weeks versus placebo
Time frame: At 12 weeks
Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo
Time frame: At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No. Not to be shared
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type 2 Diabetes Mellitus, run by KeyBioscience AG at 30 sites in 6 countries.
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 6 inclusion and 17 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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Czechia, Denmark, Poland, Romania, Moldova and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in blood HbA1c at 12 weeks versus placebo. (time frame: At 12 weeks). 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 11 Sep 2018.