Diabetes
Conditions
Keywords
Type 2
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.
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.
Interventions
DRUGplacebo
placebo capsule,0 units, quater in die (QID) for 18 weeks
DRUGOral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.
DRUGOral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.
Sponsors
Diasome Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed