| Trial ID: | L6827 |
| Source ID: | NCT02506647
|
| Associated Drug: |
Gan & Lee Insulin Glargine Followed By Lantus
|
| Title: |
PK/PD Study of Gan & Lee's Insulin Glargine Injection in Comparison to Lantus in Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Gan & Lee insulin glargine followed by Lantus|DRUG: Lantus followed by Gan & Lee insulin glargine
|
| Outcome Measures: |
Primary: Pharmacodynamic effects, Pharmacodynamic effects: Area under the glucose infusion rate, AUC GIR(0-24hr), 0-24 hours|Pharmacokinetic effects, Area under the insulin concentration-time curve, AUCINS (0-24hr), 0-24 hours | Secondary: Pharmacokinetic effects, AUCINS (0-12hr), 0-12 hours|Pharmacokinetic effects, AUCINS (12-24hr), 12-24 hours|Pharmacodynamic effects, AUCGIR (0-12hr), 0-12hours|Pharmacodynamic effects, AUCGIR (12-24hr), 12-24 hours|Safety assessment as measured by incidence and severity of adverse events, Incidence and severity of adverse events, 0-24 hours
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2015-12
|
| Completion Date: |
2016-09
|
| Results First Posted: |
|
| Last Update Posted: |
2017-01-26
|
| Locations: |
Profil Institute for Clinical Research, San Diego, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02506647
|
