Phase 4
N=24
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01449747 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment — 7.0; 6.1; 10.6; 14.1 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- The Catholic University of Korea
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment |
7.0; 6.1; 10.6; 14.1; 15.7; 14.3 | — |
| PRIMARY Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment |
25.6; 15.6; 30.5; 20.4; 36.2; 22.4 | — |
| PRIMARY Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment |
13.8; 12.3; 42.3; 40.3; 109.6; 60.2 | — |
| PRIMARY Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment |
2181.7; 1578.2; 5766.5; 3680.2; 10216.7; 7575.6 | — |
| SECONDARY Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups |
100; 100; 67.2; 40.5; 67.3; 39.2 | — |
Summary
The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4 inhibitor
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetic patients with less than 15 yrs of disease duration
- BMI between 22-27 kg/m2
- HbA1c ≤ 9% at recruitment
- Study group
After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy
- Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or
- Increase of HbA1c over 1% within 2-3 months without abrupt increase of blood glucose levels within several days
- Sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or glibenclamide 10mg
- Metformin dose : 500~2000mg
- Reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely.
- Control group
- Age, sex, BMI matched patients with same condition of study patients
- After change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea therapy, no change of blood glucose levels like above or stable HbA1c change within 1% within 2-3 months
Exclusion Criteria
- Other causes of increase of blood glucose levels except drug change
- Patients with history of insulin treatment
- Patients taking thiazolidinediones, alpha-glucosidase inhibitors, GLP-1 analogue or DPP-4 inhibitors
- Patients with renal, hepatic dysfunction
- Patients with diabetic complications such as coronary heart disease, cerebrovascular disease, proliferative diabetic retinopathy or diabetic gastroparesis
- Patients taking medications affecting glucose level
Data sourced from ClinicalTrials.gov (NCT01449747). 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.