Primary outcomeMean· 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Non-responder | 7.0 | 6.6 |
| Responder | 6.1 | 1.9 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataPharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
NCTNCT01449747 (opens ClinicalTrials.gov in a new tab)Other idCMCENDO-01
This trial does not test a peptide that PepBank tracks.
- Measures Glucagon, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 24 participants (actual)
- Sponsor
- The Catholic University of Korea · Other
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
South Korea
- Start
- Dec 2011
- Primary completion
- Aug 2014
- Completion
- Jul 2015
- First posted
- 10 Oct 2011 (estimated)
- Last update posted
- 14 Dec 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013201420152016
- Ph 4
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
NCT01449747Dec 2011 to Jul 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- SitagliptinDrug
Arms2
Active comparator
study group
sitagliptin hypo-response patients
Sham comparator
control group
sitagliptin response patients
Primary outcomes4
Outcomes the sponsor listed as primary.
Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment
Time frame · 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Registry description
Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
Time frame · 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Registry description
Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
Time frame · 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Registry description
Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
Time frame · 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Registry description
Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.
Secondary outcomes(1)
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
Time frame · 0, 15, 30, 45, 60 min post-dose
Registry description
The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Non-responder | 25.6 | 26.9 |
| Responder | 15.6 | 16.2 |
Primary outcomeMean· 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment
| Group | Value (pmol/L) | Spread |
|---|---|---|
| Non-responder | 13.8 | 4.5 |
| Responder | 12.3 | 6.9 |
Primary outcomeMean· 0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose
Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment
| Group | Value (pmol*min/L) | Spread |
|---|---|---|
| Non-responder | 2181.7 | 1099.6 |
| Responder | 1578.2 | 807.5 |
Secondary and other outcome results(1)
Secondary outcomeMean· 0, 15, 30, 45, 60 min post-dose
Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups
| Group | Value (percentage of DPP4 activity) | Spread |
|---|---|---|
| Non-responder | 100 | 0 |
| Responder | 100 | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Non-responderSitagliptin non-response patients | – | 0 / 12 | 0 / 12 |
| ResponderSitagliptin response patients | – | 0 / 12 | 0 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Type 2 diabetic patients with less than 15 yrs of disease duration
* BMI between 22-27 kg/m2
* HbA1c ≤ 9% at recruitment
1. Study group
After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy
1. Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL within several days or
2. 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
3. Reduced response to sitagliptin should be made a decision by investigators after understanding the condition of patients surely.
2\. 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
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