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| Sponsor: | Diasome Pharmaceuticals |
|---|---|
| Information provided by: | Diasome Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00521378 |
Purpose
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
| Condition |
|---|
|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patients must satisfy all of the following inclusion criteria to be included in the study:
Exclusion Criteria:
11. have a history of ketoacidosis;
12. have any acute illness within 2 weeks prior to Screening; or,
13. have elevated liver enzymes (ALT, AST, alkaline phosphatase) >1.5 times the upper limit of normal.
Contacts and Locations
More Information
| Study ID Numbers: | DP 01-2007-01 |
| Study First Received: | August 23, 2007 |
| Last Updated: | January 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00521378 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diabetes Type 1 and Type 2 Diabetes |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |