Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Study Details
Study Description
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:
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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
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To evaluate the safety and tolerability of oral HDV-I.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: 1; Placebo Patients receive a sugar pill. |
Drug: placebo
placebo capsule,0 units, quater in die (QID) for 18 weeks
|
Experimental: 2; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) Patients receive Oral HDV-Insulin (U-5). |
Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.
|
Experimental: 3; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15) Patients receive Oral HDV-Insulin (U-15). |
Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 to 70 years, inclusive;
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Diagnosis of type 2 diabetes mellitus;
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Fasting plasma glucose <=250 mg/dL;
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BMI <=45 kg/m2;
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HbA1c levels as follows at Screening:
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On a stable dose of metformin monotherapy with an HbA1c >=7.5% and <=9.5%;
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On metformin and 1 other OAD (excluding TZD, exenatide, or insulin) with an HbA1c
=6.8% and <=9.0%;
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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%;
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Understanding of the study procedures and agreement to participate in the study, giving written informed consent;
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Women may be enrolled if all of the following criteria (in addition to the above criteria) are met:
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They are not pregnant (women of childbearing potential must have a negative serum pregnancy test at Visit 1);
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They are not breast-feeding;
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They do not plan to become pregnant during the study; and
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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:
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History of type 1 diabetes and/or history of ketoacidosis;
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History of chronic (>2 months) use of insulin therapy or recent initiation of insulin use intended for chronic administration;
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Use of TZD (pioglitazone or rosiglitazone) or exenatide within 3 months prior to Screening;
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Use of prescription or over the counter weight loss agents within 1 month prior to Screening;
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Use of any lipid-altering, antihypertensive, and other chronic use medication not stable for 1 month prior to Screening;
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Use of any medication that may alter blood glucose analyses;
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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;
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Require regular use of medication that interferes with the oral absorption and/or metabolism of insulin or metformin;
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History of pancreatitis;
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History of acquired immune deficiency syndrome or human immunodeficiency virus;
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History of drug or alcohol abuse within the past 2 years;
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Hospitalization for any cause within 14 days prior to the study;
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History of an allergic or toxic response to oral HDV-I;
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Uncontrolled hypertension: systolic blood pressure >160 mmHg and diastolic blood pressure >95 mmHg;
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Triglycerides >400 mg/dL;
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Aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit of normal (ULN);
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Creatine phosphokinase >3 times the ULN;
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Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of starting the study;
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Use of any investigational drug within 30 days preceding the first dose of study medication; or
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Employment by the research center.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
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 | |
5 | Paramount | California | United States | 90723 | |
6 | Sacramento | California | United States | 95825 | |
7 | San Mateo | California | United States | 94401 | |
8 | Stockton | California | United States | 95204 | |
9 | Valley Village | California | United States | 91607 | |
10 | Walnut Creek | California | United States | 94598 | |
11 | Chiefland | Florida | United States | 32626 | |
12 | Fort Lauderdale | Florida | United States | 33308 | |
13 | Palm Harbor | Florida | United States | 34684 | |
14 | Pembroke Pines | Florida | United States | 33029 | |
15 | Atlanta | Georgia | United States | 30308 | |
16 | Atlanta | Georgia | United States | 30322 | |
17 | Topeka | Kansas | United States | 66606 | |
18 | Lexington | Kentucky | United States | 40504 | |
19 | Paducah | Kentucky | United States | 42003 | |
20 | Brockton | Massachusetts | United States | 02301 | |
21 | Picayune | Mississippi | United States | 39466 | |
22 | Omaha | Nebraska | United States | 68114 | |
23 | Staten Island | New York | United States | 10301 | |
24 | Cincinnati | Ohio | United States | 45236 | |
25 | Delaware | Ohio | United States | 43015 | |
26 | Zanesville | Ohio | United States | 43701 | |
27 | Beaver | Pennsylvania | United States | 15009 | |
28 | Kingsport | Tennessee | United States | 37660 | |
29 | Corpus Christi | Texas | United States | 78404 | |
30 | El Paso | Texas | United States | 79935 | |
31 | Houston | Texas | United States | 77074 | |
32 | Hurst | Texas | United States | 76054 | |
33 | Odessa | Texas | United States | 79761 | |
34 | San Antonio | Texas | United States | 78229 | |
35 | San Antonio | Texas | United States | 78237 | |
36 | Salt Lake City | Utah | United States | 84124 | |
37 | Manassas | Virginia | United States | 20110 | |
38 | Virginia Beach | Virginia | United States | 23454 | |
39 | Renton | Washington | United States | 98055 | |
40 | Milwaukee | Wisconsin | United States | 53209 |
Sponsors and Collaborators
- Diasome Pharmaceuticals
Investigators
- Study Director: Len Rosenberg, PhD, RPh, Diasome Pharmaceuticals
- Study Director: David Orloff, MD, Medpace, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DP 01-2007-03