NCT00814294

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Diasome Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study with a washout/stabilization period of up to 12 weeks in duration and an 18-week double-blind treatment period. There will be a total of 8 visits.

Conditions

• Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-12-24
• Last updated: 2021-05-26

Locations

40 sites across 1 country: United States