None listed
Conditions
Interventions
GROUP 1 Type of group
All patients in this study will take Colesevelam Hydrochloride 3.8 g per day every day for 52 weeks. They will be allowed to continue with other antihyperglycemic agents.
Sponsors
SANKYO PHARMA DEVELOPMENT,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who complete the WEL-301, WEL-302, or WEL-303 studies with compliance with treatment of at least 80%. 2. Women can be included if the following 3 criteria are met: A) That they are not pregnant. B) That they are not breastfeeding. C) That they do not plan to become pregnant during the study. 3. In addition to all the above criteria, women must also meet 1 of the following 3 criteria: A) Having undergone a hysterectomy or tubal ligament for at least 6 months before signing the informed consent form. B) Being in the post-menopausal period for at least 1 year. C) If they are of childbearing age, they will practice 1 of the following methods of contraception throughout the study: oral contraceptives, injectables or hormonal implants, intrauterine device, diaphragm plus spermicide or female condom plus spermicide.
Exclusion criteria
Exclusion criteria: 1) History of type 1 diabetes and / or ketoacidosis 2) History of chronic use of insulin therapy or recent initiation of insulin use for chronic administration. 3) History of dysphagia, disorders in swallowing or intestinal motility. 4) Any serious disorder including those of the pulmonary, hepatic, gastrointestinal, endocrine / metabolic type uncontrolled, hematologic / oncological, neurological and psychiatric diseases. 5) Acute coronary syndrome, percutaneous coronary intervention, temporary ischemic attack within 3 months of Visit 1 or a history of severe peripheral vascular disease. 6) History of pancreatitis. 7) Antecedents of acquired immunodeficiency syndrome or human immunodeficiency virus. 8) History of drug or alcohol abuse within the last 2 years. 9) Admission for any reason within the 14 days prior to Visit 1. 10) History of an allergic or toxic response to colesevelam or any of its components. 11) Uncontrolled hypertension. 12) serum LDL-C 500 mg / dL. 14) Body mass index (BMI)> 45 kg / m2. 15) Patients with a program with continuous weight loss or beginning of an intensive program of exercises within 4 weeks of Visit 1. 16) Treatment with WelChol within 8 weeks of Visit 1 (week -3). 17) Any laboratory value during the selection outside the range of normal values ​​unless approved by the medical monitor and the sponsor. 18) Any condition or therapy that, in the opinion of the investigator, could put the patient at risk or make the patient s participation not for their benefit. 19) Decreased mental function or any other reason that makes it difficult for the patient to comply with the requirements of the study. 20) Use of any experimental drug within 30 days preceding the first dose of the study medication. 21) Be an employee of the research center. 22) Family relationship with the sponsor or with the staff of the clinical trial center.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete physical examination. Take vital signs. Measure:Safety assessments: Clinical evaluation. Evaluation of vital signs. Timepoints:Weeks 0, 8, 16, 28, 40 and 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Body weight measurement. Laboratory tests: Serum chemistry, hematology, urinalysis, HbA1c, fasting glucose, lipid profile, BetaHCG. Measure:Body weight. Evaluation of adverse events. Laboratory exams. Timepoints:Weeks 0, 8, 16, 28, 40 and 52. | — |
Countries
Mexico, Peru, United States
Outcome results
None listed