Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus

NCT01449747 | Completed Phase 4 Results

• 1 other identifier: CMCENDO-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Dipeptidyl peptidase IV inhibitors; Glucagon-like peptide 1

Outcome Measures

Primary Outcomes (4)

• Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment

  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.

  0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose

• Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment

  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.

  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

  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.

  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

  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.

  0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose

Secondary Outcomes (1)

• Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups

  0, 15, 30, 45, 60 min post-dose

Study Arms (2)

study group

ACTIVE COMPARATOR

sitagliptin hypo-response patients

Drug: Sitagliptin

control group

SHAM COMPARATOR

sitagliptin response patients

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

Sitagliptin (100mg, per oral) once a day.

Also known as: Januvia

control group; study group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

The Catholic University of Korea; St.Paul's Hospital

Seoul, 130-709, South Korea

Location

The Catholic University of Korea; Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Ji Hyun Kim
• Organization: The Catholic University of Korea

kjhyun@catholic.ac.kr

82-2-961-4534

Study Officials

• Ji Hyun Kim, Dr

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 10, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: July 1, 2015
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

KR (2)