Effects of Vildagliptine and Glimepiride on Glucose Variability
This study is currently recruiting participants.
Verified March 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01812122
First received: March 13, 2013
Last updated: March 14, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: Glimepiride Drug: Vildagliptin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Glycemic variability index [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
- Cardiovascular disease risk factor [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- glucose profile and lipid profile [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: No ]
- hypoglycemic index [ Time Frame: before and after 3 months of each drug administration ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
|
Drug: Glimepiride Drug: Vildagliptin |
|
Experimental: Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
|
Drug: Glimepiride Drug: Vildagliptin |
Detailed Description:
We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).
Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- with type 2 DM
- with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
- who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
- who can be applied with CGMS
Exclusion Criteria:
- who has liver function abnormality or renal function abnormality
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812122
Contacts
| Contact: Hye Seung Jung, MD | +82-2-2072-0240 | jungjhs@gmail.com |
Locations
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: Kyeong Seon Park, MD +82-2-2072-2228 yurica514@gmail.com | |
Sponsors and Collaborators
Seoul National University Hospital
Investigators
| Principal Investigator: | Hye Seung Jung, MD | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | Hye Seung Jung, Assistant professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01812122 History of Changes |
| Other Study ID Numbers: | CGMS_SU_Gliptin |
| Study First Received: | March 13, 2013 |
| Last Updated: | March 14, 2013 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Vildagliptin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013