Status:
COMPLETED
Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Diasome Pharmaceuticals
Conditions:
Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00814294
Start Date
December 1 2008
End Date
September 1 2009
Last Update
May 26 2021
Active Locations (40)
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1
Muscle Shoals, Alabama, United States, 35661
2
Litchfield Park, Arizona, United States, 85340
3
Tucson, Arizona, United States, 85712
4
Concord, California, United States, 94520