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

NCT03230786 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2018-09-11

No results posted yet for this study

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

Interventions

DRUG

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

Daily subcutaneous injection

Sponsors & Collaborators

  • Nordic Bioscience A/S

    collaborator INDUSTRY

  • KeyBioscience AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-07-09
Completion
2018-07-31

Countries

  • Czechia
  • Denmark
  • Moldova
  • Poland
  • Romania
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230786 on ClinicalTrials.gov