A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel-Group, Multiple-Dose Study Assessing the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GK1-399 in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: GK1-399 (formerly TTP399)
* Drug: GK1-399 (formerly TTP399)
* Drug: GK1-399 (formerly TTP399)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female, aged 18 through 75 years at screening. Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) On a stable dose of background medication for the treatment of diabetes Body Mass Index (BMI) between 20-40 kg/m2 (inclusive) Exclusion Criteria: Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GK1-399, low dose<br> | Drug: GK1-399 (formerly TTP399)<br>* Treatment A: GK1-399 200 mg. Oral administration, twice per day.<br>|
| Experimental: GK1-399, high dose, once per day<br> | Drug: GK1-399 (formerly TTP399)<br>* Treatment B: GK1-399 800 mg. Oral administration, once per day.<br>|
| Experimental: GK1-399, high dose, twice per day<br> | Drug: GK1-399 (formerly TTP399)<br>* Treatment C: GK1-399 800 mg. Oral administration, twice per day.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dose-matched placebo. Oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of GK1-399 from plasma concentrations | Area under the plasma concentration verses time curve from time 0 to the end of the dosing interval, maximum plasma concentration | 52 time points over a 6 week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic parameters of plasma glucose | Fasting plasma glucose and postprandial plasma glucose | 52 time points over a 6 week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, Type 2 diabetes mellitus, pharmacodynamics