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

September 10, 2018 updated by: KeyBioscience AG

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

Study Overview

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo QD 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
Daily subcutaneous injection
Experimental: 30µg KBP-042 QD
Up to 30µg KBP-042 QD 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
Daily subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in blood HbA1c at 12 weeks versus placebo.
Time Frame: At 12 weeks
At 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body weight at 12 weeks versus placebo.
Time Frame: At 12 weeks
At 12 weeks
Change from baseline in fasting serum glucose at 12 weeks versus placebo
Time Frame: At 12 weeks
At 12 weeks
Change from baseline in fasting serum insulin at 12 weeks versus placebo
Time Frame: At 12 weeks
At 12 weeks
Change from baseline in fasting serum glucagon at 12 weeks versus placebo
Time Frame: At 12 weeks
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
At 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2017

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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