Trials / Terminated
TerminatedNCT01035801
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients
An OpenLabel, Multicenter, Non-randomized, ActiveControlled, SingleDose Escalation, Study to Evaluate the Pharmacodynamics,Pharmacokinetics,Safety, and Tolerability of IN-105 Under Fed Conditions In Patients With Type 1 Diabetes Mellitus
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Biocon Limited · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase in blood glucose after eating a meal. This study will also tell whether single tablet of IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin injections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IN-105 | Prandial Oral Insulin |
| DRUG | Insulin Lispro Injection | Insulin Lispro Injection |
Timeline
- Start date
- 2010-08-21
- Primary completion
- 2011-03-12
- Completion
- 2011-03-12
- First posted
- 2009-12-21
- Last updated
- 2018-01-23
Locations
5 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01035801. Inclusion in this directory is not an endorsement.