Overview

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

Status:
Completed

Trial end date:
2009-09-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Diasome Pharmaceuticals

Treatments:

Insulin
Insulin, Globin Zinc
Metformin