N/A
Completed N=61
The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01092663 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Hemoglobin A1C — 0.3; -0.1 percentage — p=>0.05
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1C |
0.3; -0.1 | >0.05 |
| PRIMARY Fasting Plasma Glucose |
-0.8; -0.6 | >0.05 |
| PRIMARY Fasting Endogenous Glucose Production |
1.0; 1.0 | >0.05 |
| PRIMARY Fasting Gluconeogenesis |
0.2; -0.3 | >0.05 |
| PRIMARY Fasting Glycogenolysis |
0.8; 1.7 | >0.05 |
| PRIMARY Fasting Plasma Glucose Clearance |
0.30; 0.27 | >0.05 |
| PRIMARY Appearance Rate of Oral Glucose |
118; -244 | =0.01 sig |
| PRIMARY Postprandial Endogenous Glucose Production |
-0.1; -0.2 | >0.05 |
| PRIMARY Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC) |
-10; -256 | >0.05 |
| PRIMARY Whole-body Glycolytic Disposal of Oral Glucose |
4; 2 | >0.05 |
| PRIMARY Postprandial Glucose (AUC) |
-1.1; -1.5 | >0.05 |
| SECONDARY Fasting Plasma C-peptide |
26; 103 | >0.05 |
| SECONDARY Fasting Plamsa Glucagon |
1; 0 | >0.05 |
| SECONDARY Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1) |
2.4; 2.8 | >0.05 |
| SECONDARY Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP) |
1.8; -1.3 | <0.05 sig |
| SECONDARY Fasting Insulin |
6; 12 | >0.05 |
| SECONDARY Postprandial Insulin (AUC) |
-13; 40 | <0.05 sig |
| SECONDARY Postprandial C-peptide (AUC) |
30; 193 | <0.05 sig |
| SECONDARY Postprandial Active GLP-1 (AUC) |
1.8; 6.6 | <0.01 sig |
| SECONDARY Postprandial Total GIP (AUC) |
-2; -5 | <0.01 sig |
| SECONDARY Postprandial Glucagon (AUC) |
-7; -4.7 | >0.05 |
Eligibility 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 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).
Data sourced from ClinicalTrials.gov (NCT01092663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.