study of two doses of oral hdv-insulin and placebo with background metformin treatment in patients with type 2 diabetes mellitus

Conditions: Diabetes

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.

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.

Eligibility criteria:
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 \ =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.

Keywords: type 2