Back to resultsLinagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
Primary Purpose
PreDiabetes, Type 2 Diabetes
Status
Completed
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Dipeptidyl-Peptidase IV Inhibitors
Sponsored by
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring glucagon-like peptide 1, Dipeptidyl peptidase inhibitor, oral glucose tolerance test, prediabetes, type 2 diabetes
Eligibility Criteria
Inclusion Criteria:
- Prediabetes diagnosed from OGTT and T2DM subjects
- HbA1c > 6.5% and <10%
- Subjects not receiving any glucose-lowering medication or just receiving metformin and/or sulphonylureas and/or alpha-glucosidase inhibitors on stable dose for at least 3 months.
- Subjects who are willing to participate and sign the informed consent form
Exclusion Criteria:
- Subjects with ketoacidosis or lactic acidosis, overt diabetes, another disease causing secondary glucose intolerance, congestive heart failure (New York Heart Association Class III or IV), myocardial infarction, stroke or ischemic attacks in past 6 months, uncontrolled severe hypertension, active liver conditions such as cirrhosis or hepatitis [elevation in liver enzymes to higher activities than double the respective normal value], moderate to severe renal insufficiency, pregnancy, breast-feeding
- Patients receiving insulin, GLP-1 receptor agonists, dipeptidyl peptidase IV inhibitors or glucose-lowering medications other than metformin /sulphonylureas /alpha-glucosidase inhibitors as treatment.
- Subjects with uncontrolled blood glucose HbA1c>10%
- Subjects who plan to move out of state / country
Sites / Locations
- Hospital Sultan Ismail
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Prediabetes Low GLP-1
Prediabetes High GLP-1
Diabetes Low GLP-1
Diabetes High GLP-1
Arm Description
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
Outcomes
Primary Outcome Measures
change from baseline in glucose after 12-week treatment
OGTT is performed at week 0 (baseline) and 12 (complete treatment). plasma glucose levels are taken at time 0,30,60,90,120 minutes during OGTT.
change from baseline in HbA1c after 12-week treatment
plasma level of fasting HbA1c is taken at week 0 and 12 of study before OGTT
change from baseline in insulin sensitivity/resistance index after 12-week treatment
OGTT is performed at week 0 (baseline) and 12. Plasma levels of glucose and insulin are taken at time 0,30,60,90,120 min during the OGTT. HOMA-IR, HOMA-IS are used to measure insulin resistance and insulin sensitivity at week 0 and week 12
Secondary Outcome Measures
change from baseline in beta-cell function after 12-week treatment
OGTT is performed at week 0 (baseline) and 12 (treatment complete). HOMS-beta, insulinogenic index, oral disposition index are used to measure beta-cell funciton at week 0 and 12
Full Information
NCT ID
NCT05290506
First Posted
February 25, 2022
Last Updated
March 13, 2022
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05290506
Brief Title
Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
Official Title
Association of Fasting GLP-1 Level With the Effect of Linagliptin After an Oral Glucose Tolerance Test in Prediabetes and Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are studies that suggest glycemic response to incretin-based therapies differs between Asians and Caucasians, whereby Asians have better response compared to Caucasians. Hence, the therapeutic response could also be augmented by difference in incretin system among various ethnicities. This study is carried out to study the effect of dipeptidyl-peptidase IV (DPPIV) inhibitors in prediabetes and T2DM patients who have different levels of GLP-1 and to determine the effect on glycemic profiles, insulin resistance/sensitivity, beta-cell functon.
Detailed Description
A 12-week, open-label, single treatment study using linagliptin is conducted in 28 prediabetes and 22 T2DM subjects who are divided into low and high fasting GLP-1 groups. Prediabetes are recruited from OGTT screening. Type 2 diabetes patients are recruited from specialised diabetes clinic and routine follow-up. A 75-g oral glucose tolerance test (OGTT) is performed at week 0 and 12. Venous blood samples were drawn at times 0 (before initiation of OGTT), 30, 60, 90, 120 min from the indwelling catheter for measurement of glucose and insulin.All prediabetes and T2DM subjects receive Linagliptin 5mg once daily for a duration of 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Type 2 Diabetes
Keywords
glucagon-like peptide 1, Dipeptidyl peptidase inhibitor, oral glucose tolerance test, prediabetes, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open-labelled, single treatment study between Low GLP-1 group and High GLP-1 group of prediabetes/type 2 diabetes
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prediabetes Low GLP-1
Arm Type
Active Comparator
Arm Description
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
Arm Title
Prediabetes High GLP-1
Arm Type
Active Comparator
Arm Description
prediabetes patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
Arm Title
Diabetes Low GLP-1
Arm Type
Active Comparator
Arm Description
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
Arm Title
Diabetes High GLP-1
Arm Type
Active Comparator
Arm Description
type 2 diabetes mellitus patients were divided into high GLP-1 and low GLP-1 groups based on the median of fasting GLP-1 level. linagliptin 5mg once daily was administered.
Intervention Type
Drug
Intervention Name(s)
Dipeptidyl-Peptidase IV Inhibitors
Other Intervention Name(s)
linagliptin
Intervention Description
All subjects were given linagliptin 5mg once daily for 12 weeks. Comparison of their OGTT response at week 0 and week 12
Primary Outcome Measure Information:
Title
change from baseline in glucose after 12-week treatment
Description
OGTT is performed at week 0 (baseline) and 12 (complete treatment). plasma glucose levels are taken at time 0,30,60,90,120 minutes during OGTT.
Time Frame
baseline to 12 weeks
Title
change from baseline in HbA1c after 12-week treatment
Description
plasma level of fasting HbA1c is taken at week 0 and 12 of study before OGTT
Time Frame
baseline to 12 weeks
Title
change from baseline in insulin sensitivity/resistance index after 12-week treatment
Description
OGTT is performed at week 0 (baseline) and 12. Plasma levels of glucose and insulin are taken at time 0,30,60,90,120 min during the OGTT. HOMA-IR, HOMA-IS are used to measure insulin resistance and insulin sensitivity at week 0 and week 12
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
change from baseline in beta-cell function after 12-week treatment
Description
OGTT is performed at week 0 (baseline) and 12 (treatment complete). HOMS-beta, insulinogenic index, oral disposition index are used to measure beta-cell funciton at week 0 and 12
Time Frame
baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prediabetes diagnosed from OGTT and T2DM subjects
HbA1c > 6.5% and <10%
Subjects not receiving any glucose-lowering medication or just receiving metformin and/or sulphonylureas and/or alpha-glucosidase inhibitors on stable dose for at least 3 months.
Subjects who are willing to participate and sign the informed consent form
Exclusion Criteria:
Subjects with ketoacidosis or lactic acidosis, overt diabetes, another disease causing secondary glucose intolerance, congestive heart failure (New York Heart Association Class III or IV), myocardial infarction, stroke or ischemic attacks in past 6 months, uncontrolled severe hypertension, active liver conditions such as cirrhosis or hepatitis [elevation in liver enzymes to higher activities than double the respective normal value], moderate to severe renal insufficiency, pregnancy, breast-feeding
Patients receiving insulin, GLP-1 receptor agonists, dipeptidyl peptidase IV inhibitors or glucose-lowering medications other than metformin /sulphonylureas /alpha-glucosidase inhibitors as treatment.
Subjects with uncontrolled blood glucose HbA1c>10%
Subjects who plan to move out of state / country
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHIAU CHONG
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
81100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
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