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

NCT03230786 | Completed Phase 2 DMC

• 2 other identifiers: KBP042/CD/0032017-001061-24
• Study Type: interventional
• Target: 255
• Locations: 6 countries
• Sites: 30

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; KBP-042

Outcome Measures

Primary Outcomes (1)

• Change from baseline in blood HbA1c at 12 weeks versus placebo.

  At 12 weeks

Secondary Outcomes (5)

• Change from baseline in body weight at 12 weeks versus placebo.

  At 12 weeks

• Change from baseline in fasting serum glucose at 12 weeks versus placebo

  At 12 weeks

• Change from baseline in fasting serum insulin at 12 weeks versus placebo

  At 12 weeks

• Change from baseline in fasting serum glucagon at 12 weeks versus placebo

  At 12 weeks

• Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo

  At 12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo QD for 12 weeks as add-on to metformin

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

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

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

Drug: Daily injection of KBP/placebo for 12 weeks as add-on to metformin

Interventions

Daily injection of KBP/placebo for 12 weeks as add-on to metformin DRUG

Daily subcutaneous injection

15µg KBP-042 QD; 30µg KBP-042 QD; 50µg KBP-042 QD; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• KeyBioscience AG: lead
• Nordic Bioscience A/S: collaborator

Study Sites (30)

Diabetologická a Obezitologická ambulance

České Budějovice, Czechia

Location

Vdoviak Miroslav MUDr. - Interní Ambulance

Karlovy Vary, 360 17, Czechia

Location

Interní a Diabetologická ambulance, Clintrial s.r.o

Prague, 100 00, Czechia

Location

Endokrinologicky Ústav

Prague, 113 94, Czechia

Location

General University Hospital

Prague, 128 00, Czechia

Location

Institute for Clinical and experimental Medicine

Prague, 140 21, Czechia

Location

Diabet2 s.r.o

Prague, Czechia

Location

Interní a Diabetologická ambulance

Uherské Hradiště, 68 601, Czechia

Location

Bispebjerg Hospital, Endokrinologisk Afdeling

Bispebjerg, Copenhagen NV, 2400, Denmark

Location

Bioclinica

Ballerup Municipality, Copenhagen, 2750, Denmark

Location

Bioclinica

Aalborg, Jutland, 9000, Denmark

Location

Aarhus University Hospital, Endocrinlogy Department

Aarhus, Jutland, 8000, Denmark

Location

Sydvestjysk Sygehus

Esbjerg, Jutland, 6700, Denmark

Location

Bioclinica

Vejle, Jutland, 7100, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Rtl Sm Srl/Scr

Chisinau, MD2025, Moldova

Location

Rtl Sm Srl

Chisinau, MD2025, Moldova

Location

Centrum Badań Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

Location

Specjalistyczna Praktyka Lekarska Piotr Kubalski

Grudziądz, 86-302, Poland

Location

Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno

Krakow, 31-261, Poland

Location

Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer

Lodz, 90-074, Poland

Location

Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus)

Opole, 45-367, Poland

Location

Centrum Medyczne Hygea

Tychy, 43-100, Poland

Location

Centrum Medyczne AMED

Warsaw, 01-518, Poland

Location

S.C. Policlinica CCBR S.R.L.

Bucharest, 030463, Romania

Location

Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu"

Bucharest, Romania

Location

S.C Nicodiab S.R.L.

Bucharest, Romania

Location

S.C. Sfinx Medica S.R.L.

Constanța, 900412, Romania

Location

S.C. Mediab S.R.L.

Târgu Mureş, Romania

Location

St. Pancras

London, WC1X 8QD, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: August 23, 2017
• Primary Completion: July 9, 2018
• Study Completion: July 31, 2018
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); RO (5); MO (2); DK (7); CZ (8); GB (1)