Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290506
• Other study ID #: Linagliptin study
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Drug:
• Dipeptidyl-Peptidase IV Inhibitors
All subjects were given linagliptin 5mg once daily for 12 weeks. Comparison of their OGTT response at week 0 and week 12

Locations

Country	Name	City	State
Malaysia	Hospital Sultan Ismail	Johor Bahru	Johor

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to 12 weeks
Primary	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	baseline to 12 weeks
Primary	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	baseline to 12 weeks
Secondary	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	baseline to 12 weeks