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

KineMed

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sitagliptin; Drug: Colesevelam HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01092663

KM-29

Details and patient eligibility

About

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

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Colesevelam HCl: 3 tablets, 2x/day

Active Comparator group

Description:

Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.

Treatment:

Drug: Colesevelam HCl

Colesevelam plus Sitagliptin

Active Comparator group

Description:

Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Treatment:

Drug: Colesevelam HCl

Drug: Sitagliptin