Type 2 diabetes mellitus (T2DM) MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Forest Research Institute, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in the study, patients must meet the following criteria: 1. Be able to understand and provide written informed consent before any study-related procedures are conducted 2. Have successfully completed either core study DUT-MD-303 or DUT-MD-304. Patients who received rescue therapy but still completed the core study are also eligible 3. Be currently receiving treatment for T2DM as set forth in either core study DUT-MD-303 or DUT-MD-304 4. If female, must not be pregnant, not planning to become pregnant during the course of the study, and not lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 5. If of childbearing potential (or having partner[s] of childbearing potential), must be willing to use adequate contraception and not become pregnant (or have partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include but are not limited to oral contraceptives (stable use for 2 or more cycles before screening); intrauterine devices; Depo-Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence 6. Be willing to refrain from donating blood during the study and for up to 1 month after completing the study 7. Be willing to refrain from receiving treatment with any IP other than those outlined in this protocol or participating in any other investigational study during the course of this study 8. Be willing to return for required clinic visits and complete study-related procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet the following criteria will not be eligible to participate in the study: 1. Have an unresolved AE or a clinically significant finding on a physical examination, clinical laboratory test, or electrocardiogram (ECG) that, in the opinion of the PI, would limit the patient’s ability to participate in or complete this study 2. Have any condition, disease, or disorder that, in the opinion of the PI, would jeopardize the patient’s appropriate participation in this study or obscure the effects of treatment 3. Have any of the following at Visit 1 based on clinical laboratory results: - Total bilirubin level above the upper limit of normal (ULN), unless associated with an elevated indirect bilirubin typical of Gilbert syndrome - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 1.5 times the ULN - Alkaline phosphatase level > 1.5 times the ULN Note: The Investigator should review the laboratory test results before Visit 2. If the patient must be excluded based on the laboratory results, he or she should be asked to come back to the study center to complete an Early Termination Visit. 4. Have a glomerular filtration rate (GFR) < 50 mL/min/1.73 m2, as estimated by the central laboratory using the Modification of Diet in Renal Disease (MDRD) study equation at Visit 1 Note: The Investigator should review the laboratory test results before Visit 2. If the patient must be excluded based on the laboratory results, he or she should be asked to come back to the study center to complete an Early Termination Visit. 5. Have a history of infection with human immunodeficiency virus 6. Have serologic evidence of current infection (acute or chronic) with hepatitis B virus or hepatitis C virus as determined by the central laboratory at Visit 1 Note: The Investigator should review the laboratory test results before Visit 2. If the patient must be excluded based on the laboratory results, he or she should be asked to come back to the study center to complete an Early Termination Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the long-term safety of dutogliptin in patients with type 2 diabetes mellitus;Secondary Objective: To demonstrate the long-term efficacy of dutogliptin in patients with type 2 diabetes mellitus;Primary end point(s): Adverse events, laboratory parameters, vital signs, electrocardiograms, and targeted physical examination findings | — |
Countries
Hungary
Outcome results
None listed