PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
Public ClinicalTrials.gov record NCT02506647. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, Exploratory, Randomized, Double-Blind, Two-Way Cross Over Study to Assess Pharmacokinetic and Pharmacodynamic Effects of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Subjects With Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02506647
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 41 participants
Conditions and interventions
Conditions
Interventions
- Gan & Lee insulin glargine followed by Lantus Drug
- Lantus followed by Gan & Lee insulin glargine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2015 (Actual)
- Primary completion
- Sep 2016 (Actual)
- Completion
- Sep 2016 (Actual)
- Last update posted
- Jan 26, 2017
2015 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Profil Institute for Clinical Research | San Diego | California | 91911 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02506647, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 26, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02506647 live on ClinicalTrials.gov.