Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus

National University of Malaysia

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes; PreDiabetes

Treatments: Drug: Dipeptidyl-Peptidase IV Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT05290506

Linagliptin study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Prediabetes Low GLP-1

Active Comparator group

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.

Treatment:

Drug: Dipeptidyl-Peptidase IV Inhibitors

Prediabetes High GLP-1

Active Comparator group

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.

Treatment:

Drug: Dipeptidyl-Peptidase IV Inhibitors

Diabetes Low GLP-1

Active Comparator group

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.

Treatment:

Drug: Dipeptidyl-Peptidase IV Inhibitors

Diabetes High GLP-1

Active Comparator group

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.

Treatment:

Drug: Dipeptidyl-Peptidase IV Inhibitors