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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814294
• Other study ID #: DP 01-2007-03
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2021
• Source: Diasome Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

• They are not pregnant (women of childbearing potential must have a negative serum pregnancy test at Visit 1);

• They are not breast-feeding;

• They do not plan to become pregnant during the study; and

• They have had a hysterectomy or tubal ligation 6 months prior to the study, have been post-menopausal for 1 year, or will practice a method of birth control throughout the study.

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;

• History of drug or alcohol abuse within the past 2 years;

• Hospitalization for any cause within 14 days prior to the study;

• History of an allergic or toxic response to oral HDV-I;

• Uncontrolled hypertension: systolic blood pressure >160 mmHg and diastolic blood pressure >95 mmHg;

• Triglycerides >400 mg/dL;

• Aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit of normal (ULN);

• Creatine phosphokinase >3 times the ULN;

• Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of starting the study;

• Use of any investigational drug within 30 days preceding the first dose of study medication; or

• Employment by the research center.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• placebo
placebo capsule,0 units, quater in die (QID) for 18 weeks
• Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.
• Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diasome Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 weeks
Secondary	To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test		18 weeks
Secondary	To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin		18 weeks
Secondary	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 ß-cell function (HOMA-ß)		18 Weeks
Secondary	To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels		18 Weeks