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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Diasome Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Diasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00814294
First received: December 23, 2008
Last updated: June 29, 2009
Last verified: June 2009

December 23, 2008
June 29, 2009
December 2008
September 2009   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814294 on ClinicalTrials.gov Archive Site
  • To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the effects of oral HDV-I versus placebo on frequency of hypoglycemic events, body weight, and lipid levels [ Time Frame: 18 Weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes
  • Drug: placebo
    placebo capsule,0 units, QID for 18 weeks
  • Drug: Oral HDV-I
    Oral HDV-I Caps; 15 U; QID for 18 weeks.
  • Drug: Oral HDV-Insulin
    Oral HDV-I; Caps; 5 U; QID for 18 weeks.
  • Placebo Comparator: 1
    Patients on metformin will remain on their stable dose and receive a sugar pill.
    Intervention: Drug: placebo
  • Experimental: 2; Oral HDV-Insulin
    Patients on a stable dose of metformin will receive Oral HDV-I.
    Intervention: Drug: Oral HDV-Insulin
  • Experimental: 3; Oral HDV-Insulin
    Patients on a stable dose of metformin will receive Oral HDV-I.
    Intervention: Drug: Oral HDV-I
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
October 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814294
DP 01-2007-03
No
Len Rosenberg, President, Disaome Pharmaceuticals
Diasome Pharmaceuticals
Not Provided
Study Director: Len Rosenberg, PhD, RPh Diasome Pharmaceuticals
Study Director: David Orloff, MD Medpace, Inc.
Diasome Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP