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

Sponsor
Diasome Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00814294
Collaborator
(none)
239
40
3
9
6
0.7

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:
  • 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: placebo
  • Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
  • Drug: Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
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

Study Type:
Interventional
Actual Enrollment :
239 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

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

  1. 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

  1. To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test [18 weeks]

  2. To evaluate the effects of oral HDV-I versus placebo on fasting plasma glucose (FPG) and insulin [18 weeks]

  3. 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]

  4. 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

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Diasome Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00814294
Other Study ID Numbers:
  • DP 01-2007-03
First Posted:
Dec 24, 2008
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Keywords provided by Diasome Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2021