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

Diasome Pharmaceuticals0 sites239 target enrollmentDecember 2008

Interventionsplacebo Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Drugsplacebo Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Diabetes
Sponsor: Diasome Pharmaceuticals
Enrollment: 239
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

September 2009

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Diasome Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 70 years, inclusive;
•Diagnosis of type 2 diabetes mellitus;
•Fasting plasma glucose \<=250 mg/dL;
•BMI \<=45 kg/m2;
•HbA1c levels as follows at Screening:
•On a stable dose of metformin monotherapy with an HbA1c \>=7.5% and \<=9.5%;
•On metformin and 1 other OAD (excluding TZD, exenatide, or insulin) with an HbA1c \>=6.8% and \<=9.0%;
•Naïve to antidiabetic therapy or have not been on a stable dose of metformin monotherapy for \<12 weeks with an HbA1c \>=8.0% and \<=10.5%;
•Understanding of the study procedures and agreement to participate in the study, giving written informed consent;
•Women may be enrolled if all of the following criteria (in addition to the above criteria) are met:

Exclusion Criteria

•History of type 1 diabetes and/or history of ketoacidosis;
•History of chronic (\>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;
•Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;
•Use of prescription or over the counter weight loss agents within 1 month prior to Screening;
•Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;
•Use of any medication that may alter blood glucose analyses;
•Any serious disorder including cardiac, pulmonary, hepatic, uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
•Require regular use of medication that interferes with the oral absorption and/or metabolism of insulin or metformin;
•History of pancreatitis;
•History of acquired immune deficiency syndrome or human immunodeficiency virus;

Arms & Interventions

1; Placebo

Patients receive a sugar pill.

Intervention: placebo

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

Patients receive Oral HDV-Insulin (U-5).

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

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

Patients receive Oral HDV-Insulin (U-15).

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

Outcomes

Primary Outcomes

Time Frame: 18 weeks

Secondary Outcomes

To evaluate the effects of oral HDV-I versus placebo on the homeostasis model assessment of insulin resistance (HOMA-IR)and homeostasis model assessment of β-cell function (HOMA-β)(18 Weeks)
To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels(18 Weeks)
To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test(18 weeks)
To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin(18 weeks)