None listed
Conditions
Interventions
Group 1 Type of group
Single blind period: Duration of 2 weeks. Patients will take COLESEVELAM PLACEBO CHLORHYDRATE either with lunch or at dinner (3 tablets at a time) or they can take the 6 tablets at dinner.
Double-blind period: Duration of 26 weeks. Patients will take COLESEVELAM (WELCHOL®) 3.8 g / day either with lunch or at dinner (3 tablets each time) or they can take the 6 tablets at dinner. Patients will continue to take their sulphonylurea and any other oral antidiabetic medication in the same way they w
Single blind period: Duration of 2 weeks. Patients will take COLESEVELAM PLACEBO CHLORHYDRATE either with lunch or at dinner (3 tablets at a time) or they can take the 6 tablets at dinner. Double-blind period: Duration of 26 weeks. Patients will continue taking COLESEVELAM PLACEBO CHLORHYDRATE either with lunch or at dinner (3 tablets at a time) or they may take the 6 tablets at dinner.
Patients will continue to take their sulphonylurea and any other oral antidiabetic medication in the same w
Sponsors
SANKYO PHARMA DEVELOPMENT,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: between 18 and 75 years inclusive. 2) Diagnosis of type 2 diabetes mellitus. 3) Have prescribed a diet accepted by ADA. 4) Be receiving a stable, optimal dose of a sulphonylurea alone or in combination with other oral antidiabetic medications for 90 days before Visit 1. 5) If you are receiving other oral antidiabetic medications, the dose was stable for 90 days before Visit 1. 5) Understand the study procedures and agree to participate in the study by signing the informed consent. 6) 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. 7) 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:Seric HbA1c Measure:Change in HbA1c from baseline to the end of treatment Timepoints:Basal and at week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Serum HbA1C. Fasting blood glucose. Serum fructosamine. Levels of serum insulin. Peptide C. Homeostasis model (HOMA). Adiponectin High sensitivity C-reactive protein (hsCRP). Lipid profile: LDL-C, no HDL-C, TG, TC, HDL-C, Apo A-I, Apo B Measure:1) Change in baseline HbA1C. 2) Changes in fasting glucose and fructosamine. 3) Glycemic control response rate. 4) Insulin sensitivity and changes in insulin. 5) Change in hsCRP. 6) Changes in the lipid profile. Timepoints:Serum HbA1C: weeks 6, 12 and 18. Fasting glucose: Basal, weeks 6, 18, 26. Fructosamine: Basal, weeks 6, 18, 26. Serum insulin: Basal and week 26. Peptide C: Basal and week 26. Adiponectin: Basal and week 26. High sensitivity C-reactive protein (hsCRP): Basal and week 26. Lipid profile: Basal and week 26. ; Outcome name:Clinical evaluation Measurement of body weight. Evaluation of adverse effects. Serum chemistry, hematology and urinalysis. Measure:Treatment safety Timepoints:Clinical evaluation: Weeks -2 and 26. Measurement of body weight: Weeks 0 and 26. Evaluation of adverse effects: Weeks -2 and 26. Serum chemistry, hematology and urinalysis: Semanss: 12 and 26. | — |
Countries
Mexico, Peru, United States
Outcome results
None listed