Type 2 Diabetes
Conditions
Keywords
Diabetes mellitus
Brief summary
The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs
Interventions
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 - 75 years, inclusive * Diagnosed with type 2 diabetes * Stable insulin therapy for 6 weeks * Stable dose of any other antidiabetic medications for 90 days * Hemoglobin A1c value between 7.5% to 9.5% * C peptide greater than 0.5 ng/mL * Prescribed ADA diet
Exclusion criteria
* History of type 1 diabetes or ketoacidosis * History of pancreatitis * Uncontrolled hypertension * Allergy or toxic response to colesevelam or any of its components * Serum LDL-C less than 60 mg/dL * Serum TG greater than 500 mg/dL * Body mass index (BMI) greater than 45 kg/m2-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the additional lowering of HbA1c achieved by | — |
| addition of WelChol® to current antidiabetic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess: the effects on fasting plasma glucose and | — |
| fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add- | — |
| on therapy to patients receiving insulin alone or with | — |
| other oral drugs | — |
Countries
Mexico, Peru, United States
Outcome results
None listed