The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KineMed
• Treatments: Colesevelam Hydrochloride; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).