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Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03230786
Recruitment Status : Active, not recruiting
First Posted : July 26, 2017
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Nordic Bioscience A/S
Information provided by (Responsible Party):
KeyBioscience AG

Brief 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.

The trial is planned to be performed in Czech Republic, Denmark, Moldova, Poland, Romania and United Kingdom


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
Actual Study Start Date : August 23, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo QD for 12 weeks as add-on to metformin
Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Daily subcutaneous injection

Experimental: 15µg KBP-042 QD
Up to 15µg KBP-042 QD for 12 weeks as add-on to metformin
Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Daily subcutaneous injection

Experimental: 30µg KBP-042 QD
Up to 30µg KBP-042 QD for 12 weeks as add-on to metformin
Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Daily subcutaneous injection

Experimental: 50µg KBP-042 QD
Up to 50µg KBP-042 QD for 12 weeks as add-on to metformin
Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Daily subcutaneous injection




Primary Outcome Measures :
  1. Change from baseline in blood HbA1c at 12 weeks versus placebo. [ Time Frame: At 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in body weight at 12 weeks versus placebo. [ Time Frame: At 12 weeks ]
  2. Change from baseline in fasting serum glucose at 12 weeks versus placebo [ Time Frame: At 12 weeks ]
  3. Change from baseline in fasting serum insulin at 12 weeks versus placebo [ Time Frame: At 12 weeks ]
  4. Change from baseline in fasting serum glucagon at 12 weeks versus placebo [ Time Frame: At 12 weeks ]
  5. Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo [ Time Frame: At 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 in the use of highly effective method of contraception by the female partner throughout the trial period.
  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 randomization) 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.

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 (dipeptidyl peptidase 4 inhibitors), GLP-1 (Glucagon-like peptide 1) analogues, insulin and sulfonylureas, for a period of 90 days prior to randomization.
  8. Use of thiazolidinediones (glitazones) 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. Breast-feeding women.
  15. Known positive test results for hepatitis C antibodies, hepatitis B surface antigen, and HIV at screening.
  16. 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.
  17. Clinically significant ECG abnormalities, as judged by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230786


Locations
Czechia
Vdoviak Miroslav MUDr. - Interní Ambulance
Karlovy Vary, Czechia, 360 17
General University Hospital
Prague 2, Czechia, 128 00
Institute for Clinical and experimental Medicine
Praha 4, Czechia, 140 21
Interní a Diabetologická ambulance, Clintrial s.r.o
Praha, Czechia, 100 00
Endokrinologicky Ústav
Praha, Czechia, 113 94
Diabet2 s.r.o
Praha, Czechia
Interní a Diabetologická ambulance
Uherské Hradiště, Czechia, 68 601
Diabetologická a Obezitologická ambulance
České Budějovice, Czechia
Denmark
Bispebjerg Hospital, Endokrinologisk Afdeling
Bispebjerg, Copenhagen NV, Denmark, 2400
Bioclinica
Ballerup, Copenhagen, Denmark, 2750
Bioclinica
Aalborg, Jutland, Denmark, 9000
Aarhus University Hospital, Endocrinlogy Department
Aarhus, Jutland, Denmark, 8000
Sydvestjysk Sygehus
Esbjerg, Jutland, Denmark, 6700
Bioclinica
Vejle, Jutland, Denmark, 7100
Holbæk Sygehus
Holbæk, Denmark, 4300
Moldova, Republic of
Rtl Sm Srl/Scr
Chisinau, Moldova, Republic of, MD2025
Rtl Sm Srl
Chisinau, Moldova, Republic of, MD2025
Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdańsk, Poland, 80-546
Specjalistyczna Praktyka Lekarska Piotr Kubalski
Grudziądz, Poland, 86-302
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno
Kraków, Poland, 31-261
Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)
Opole, Poland, 45-367
Centrum Medyczne Hygea
Tychy, Poland, 43-100
Centrum Medyczne AMED
Warsaw, Poland, 01-518
Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer
Łódź, Poland, 90-074
Romania
S.C. Policlinica CCBR S.R.L.
Bucharest, Romania, 030463
Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"
Bucharest, Romania
S.C Nicodiab S.R.L.
Bucharest, Romania
S.C. Sfinx Medica S.R.L.
Constanţa, Romania, 900412
S.C. Mediab S.R.L.
Targu Mures, Romania
S.C. Mediab S.R.L.
Târgu-Mureş, Romania
United Kingdom
St. Pancras
London, United Kingdom, WC1X 8QD
Sponsors and Collaborators
KeyBioscience AG
Nordic Bioscience A/S

Responsible Party: KeyBioscience AG
ClinicalTrials.gov Identifier: NCT03230786     History of Changes
Other Study ID Numbers: KBP042/CD/003
2017-001061-24 ( EudraCT Number )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not to be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KeyBioscience AG:
Type 2 Diabetes Mellitus
KBP-042

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Calcitonin
Hypoglycemic Agents
Physiological Effects of Drugs
Bone Density Conservation Agents