Overview

This trial is active, not recruiting.

Condition diabetes
Treatments placebo, oral hdv-i, oral hdv-insulin
Phase phase 2/phase 3
Sponsor Diasome Pharmaceuticals
Start date December 2008
End date September 2009
Trial size 230 participants
Trial identifier NCT00814294, DP 01-2007-03

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Patients on metformin will remain on their stable dose and receive a sugar pill.
placebo
placebo capsule,0 units, QID for 18 weeks
(Experimental)
Patients on a stable dose of metformin will receive Oral HDV-I.
oral hdv-insulin
Oral HDV-I; Caps; 5 U; QID for 18 weeks.
(Experimental)
Patients on a stable dose of metformin will receive Oral HDV-I.
oral hdv-i
Oral HDV-I Caps; 15 U; QID for 18 weeks.

Primary Outcomes

Measure
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.
time frame: 18 weeks

Secondary Outcomes

Measure
To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test
time frame: 18 weeks
To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin
time frame: 18 weeks
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)
time frame: 18 Weeks
To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels
time frame: 18 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2009.
Information provided to ClinicalTrials.gov by Diasome Pharmaceuticals.