Study of Comparing the Different Effect of DPP-4 Inhibitors and Sulfonylurea by Using "Biphase-Hyperglycemic Clamp"

NCT01660386 | Unknown Phase 4 DMC

• 1 other identifier: CCEMD014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to demonstrate the different effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin)and the insulin secretagogue: glimepiride on first and second phase insulin secretion by using a Biphase-Hyperglycemic Clamp and to explore the different effects of the study drugs on the GLP-1 response, and the glucagon concentration which indicates alpha cell function in healthy subjects.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Dpp-4 inhibitor; Sulfonylurea; beta cell function

Outcome Measures

Primary Outcomes (1)

• The acute phase and second phase of insulin secretion and C peptide secretion

  The primary outcome measures are improvement in beta cell function measured as insulin secretion and C-peptide secretion during the bi-phase hyperglycaemic clamp. The first phase of insulin and C-peptide secretion is defined as the secretion between 0-10min, the second phase is defined as secretion between 20-90min of bi-phase hyperglycaemic clamp

  1-2 months

Secondary Outcomes (1)

• Alpha cell function,GLP-1 response

  1-2 months

Study Arms (4)

Sitagliptin

EXPERIMENTAL

the subjects are asked to take one pill of sitagliptin(100mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am.

Drug: Sitagliptin

Saxagliptin

EXPERIMENTAL

the subjects are asked to take one pill of saxagliptin(5mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am.

Drug: Saxagliptin

Glimepiride

EXPERIMENTAL

the subjects are asked to take one pill of glimepiride(2mg po once) in 7am of experimental day then start bi-phase hyperglycaemic clamp at 9am.

Drug: Glimepiride

Blank control

OTHER

the subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am.

Drug: Blank control

Interventions

Sitagliptin DRUG

100mg po once

Also known as: Januvia

Sitagliptin

Saxagliptin DRUG

5mg po once

Also known as: Onglyza

Saxagliptin

Glimepiride DRUG

2mg po once

Also known as: Amaryl

Glimepiride

Blank control DRUG

the subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am.

Also known as: Baseline

Blank control

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted;
• Having good study compliance;
• Healthy Male subjects between 20-30 years of age (inclusive), and in good health as determined by past medical history, physical examination, vital signs, and clinical laboratory test;
• Must have a body mass index (BMI) between 19-25kg/m2 (inclusive);
• No weight fluctuation greater than 5% in late 3 months。

You may not qualify if:

• With impaired glucose tolerance, T2DM or any significant medical condition (within 3 years), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;
• Used any prescribed systemic or topical medication within 30 days of the first dose administration;
• Any medical or surgical conditions possibly affecting study drug absorption, distribution, metabolism and excretion;
• Participated in a clinical study involving administration of an investigational drug within 90 days preceding the first dose administration or within five half-lives of the first dose administration (whichever is longer);
• Donated blood or plasma or had any other significant blood loss within 2 months preceding the first dose administration;
• History of multiple drug allergies;
• Any clinically significant allergic disease;
• Recently drug or alcohol abuse (\>35 unit/week, 1 unit=8g alcohol @ 1 standard drink @ 250ml beer @ 140ml wine @ 25ml strong alcohol drink like whiskey);
• Smokers or users of other tobacco products in the 3 months prior to screening.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, 200021, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; saxagliptin; glimepiride; BaseLine dental cement

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

Study Officials

• Guang Ning, MD. PHD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD. PHD

CONTACT

+8621-64370045; guangning@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the vice-president of Shanghai Jiao Tong University affiliated Rui jin Hospital

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 8, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

CN (1)