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Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

NCT00814294 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2021-05-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

placebo

placebo capsule,0 units, quater in die (QID) for 18 weeks

DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

Sponsors & Collaborators

  • Diasome Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Len Rosenberg, PhD, RPh · Diasome Pharmaceuticals

  • David Orloff, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814294 on ClinicalTrials.gov