Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT00814294. 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
An 18-Week Randomized, Double-Blind, Multicenter, Comparator Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment. The secondary objectives are: * To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and * To evaluate the safety and tolerability of oral HDV-I.
Study identification
- NCT ID
- NCT00814294
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 239 participants
Conditions and interventions
Conditions
Interventions
- placebo Drug
- Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15) Drug
- Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 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 2008 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Sep 2009 (Actual)
- Last update posted
- May 26, 2021
2008 – 2009
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Muscle Shoals | Alabama | 35661 | — |
| Not listed | Litchfield Park | Arizona | 85340 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Not listed | Concord | California | 94520 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Sacramento | California | 95825 | — |
| Not listed | San Mateo | California | 94401 | — |
| Not listed | Stockton | California | 95204 | — |
| Not listed | Valley Village | California | 91607 | — |
| Not listed | Walnut Creek | California | 94598 | — |
| Not listed | Chiefland | Florida | 32626 | — |
| Not listed | Fort Lauderdale | Florida | 33308 | — |
| Not listed | Palm Harbor | Florida | 34684 | — |
| Not listed | Pembroke Pines | Florida | 33029 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Topeka | Kansas | 66606 | — |
| Not listed | Lexington | Kentucky | 40504 | — |
| Not listed | Paducah | Kentucky | 42003 | — |
| Not listed | Brockton | Massachusetts | 02301 | — |
| Not listed | Picayune | Mississippi | 39466 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Staten Island | New York | 10301 | — |
| Not listed | Cincinnati | Ohio | 45236 | — |
| Not listed | Delaware | Ohio | 43015 | — |
| Not listed | Zanesville | Ohio | 43701 | — |
| Not listed | Beaver | Pennsylvania | 15009 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Corpus Christi | Texas | 78404 | — |
| Not listed | El Paso | Texas | 79935 | — |
| Not listed | Houston | Texas | 77074 | — |
| Not listed | Hurst | Texas | 76054 | — |
| Not listed | Odessa | Texas | 79761 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | San Antonio | Texas | 78237 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
| Not listed | Manassas | Virginia | 20110 | — |
| Not listed | Virginia Beach | Virginia | 23454 | — |
| Not listed | Renton | Washington | 98055 | — |
| Not listed | Milwaukee | Wisconsin | 53209 | — |
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 NCT00814294, 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 May 26, 2021 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00814294 live on ClinicalTrials.gov.