Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
KineMed
The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by
1. improving the effects of colesevelam on fasting glucose metabolism
2. improving the effects of colsevelam on postprandial glucose metabolism
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or Female
Females of childbearing potential are on approved birth control method
Negative pregnancy testing for females of childbearing potential
Previously diagnosed or newly diagnosed with T2DM drug naïve subjects
HbA1c: 6.7-10%
Age 18 - 80 years
BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2
Fasting serum glucose \< 300 mg/dL
Normal liver function, normal thyroid function, no history of liver, biliary or intestinal disease
Normal TSH
On stable diet and exercise routine for at least 4 weeks prior to screening
Has had a stable weight (+/-5%) for ≥3 months before screening
You may not be if
A history of type 1 diabetes mellitus or history of diabetic ketoacidosis
History of chronic (required daily for \> 2 months) use of insulin therapy
Treatment with blood pressure lowering therapy that has not been stable for three months before screening
Treatment with lipid lowering medication other than statins
Treatment with statins that has not been stable for three months before screening
Treatment with a DPP-4 inhibitor or and GLP1 agonists at any time
Treatment with a thiazolidinedione (TZD) within the last 6 months of screening
History of an allergic or toxic reaction to sitagliptin or colesevelam
History of dysphagia, swallowing disorders, bowel obstruction, intestinal motility disorder, and gastrointestinal disorders
History of major gastrointestinal surgery
History of kidney problems
Fasting plasma triglycerides \> 300 mg/dL
Serum LDL-C \<60 mg/dL
Positive toxicology test
Known hypersensitivity to colesevelam HCl or sitagliptin.
Any contraindications to a study medication (colesevelam HCl or sitagliptin).
Clareo Health | The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus
