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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01474083

Enrollment

248

Registered

2011-11-18

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2013-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, pharmacokinetics, pharmacodynamics

Brief summary

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.

Interventions

DRUGGK1-399 (formerly TTP399)

Treatment A: GK1-399 200 mg. Oral administration, twice per day.

DRUGPlacebo

Dose-matched placebo. Oral administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Pharmacodynamic parameters of plasma glucose	52 time points over a 6 week period	Fasting plasma glucose and postprandial plasma glucose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026