A Study to Evaluate the Safety and Effectiveness of DM199 in Healthy Subjects and Type 2 Diabetes Patients

Diabetes Type 2 Clinical Trial

Official title: A Double-Blinded, Placebo-Controlled, Single-Dose and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof of Concept of DM199 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Status Completed

Clinical Trial Summary

DM199 (recombinant human tissue kallikrein-1) is a new investigational compound that may eventually be used for the treatment of Diabetes Mellitus Type 2. This is the first time that this compound is being given to humans.

The purpose of the study is to investigate to what extent DM199 is safe and tolerated. Further, it will be investigated how quickly and to what extent DM99 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the compound on the body will be investigated (this is called pharmacodynamics).

This study is not intended to improve anyone's health, but is necessary for the further development of DM199.

The study consists of 4 parts. Each part (A, B, C and D) will consist of one or several periods. The research will be conducted in healthy male and female volunteers (Part A and C) and in male and female type 2 diabetes mellitus patients (Part B and D).

Clinical Trial Description

DM199 (recombinant human tissue kallikrein-1) is being developed as a new biological treatment for type 2 diabetes mellitus. This is a first-in-human study for DM199 and is a 4-part, single center study in healthy subjects and type 2 diabetes mellitus patients.

Part A will be a randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and/or female subjects. Subjects will receive DM199 or placebo subcutaneously (sc).

Part B will be a randomized, partially double-blinded, placebo-controlled, sequential SAD study in male and/or female type 2 diabetes mellitus patients.

Part C will be a randomized, double-blinded, placebo-controlled, 14-day multiple ascending dose (MAD) study in healthy male and/or female subjects each. Subjects will receive sequential doses of DM-199 or placebo sc for 14 days.

Part D will be a randomized, double-blinded, placebo-controlled, 28-day multiple-dose proof of concept (POC) study in male and/or female type 2 diabetes mellitus patients. Subjects will receive parallel doses of DM199 or placebo sc for 28 days.

The primary objective is to evaluate the safety and tolerability of single and multiple subcutaneous doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Another objective is to determine the plasma pharmacokinetic profile of DM199 after administration of single and multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients.

Secondary objectives include determining the effect of DM199 on glucose homeostasis (via fasting glucose and HbA1c levels), standardized meal tolerance test, C-peptide, fructosamine, GLP-1 (active and total), glucagon, adiponectin and lipids measurements, and homeostatic model assessment of insulin resistance/beta cell function (HOMA) determination in type 2 diabetes mellitus patients; assessing the formation of antibodies to DM199 after administration of multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients; and determining changes in immune cell populations by fluorescence-activated cell sorting analysis following multiple doses of DM199 in healthy subjects and type 2 diabetes mellitus patients ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT01845064
• Study type: Interventional
• Source: DiaMedica USA Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Completion date: November 2014