MedTrace Logo

PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes

NCT02506647 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-01-26

No results posted yet for this study

Summary

This is a Phase 1, exploratory, single dose, randomized, double-blind, two-way cross over, pilot, glucose clamp study to assess pharmacokinetic and pharmacodynamic effects of Gan \& Lee's insulin glargine injection in comparison to the marketed Lantus (US) in subjects with type 1 diabetes mellitus (T1DM).

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Gan & Lee insulin glargine followed by Lantus

0.4 IU/kg Gan \& Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC

DRUG

Lantus followed by Gan & Lee insulin glargine

Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan \& Lee insulin glargine injection SC,

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

  • Marcus Hompesch, MD · Profil Institute for Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02506647 on ClinicalTrials.gov