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NCT Number: NCT05290506

Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Type 2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Sultan Ismail

Johor Bahru, Johor, 81100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dipeptidyl-Peptidase IV Inhibitors

Drug

All subjects were given linagliptin 5mg once daily for 12 weeks. Comparison of their OGTT response at week 0 and week 12

Other names: linagliptin

Primary outcomes

  1. change from baseline in glucose after 12-week treatment

    Time frame: baseline to 12 weeks

    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.

  2. change from baseline in HbA1c after 12-week treatment

    Time frame: baseline to 12 weeks

    plasma level of fasting HbA1c is taken at week 0 and 12 of study before OGTT

  3. change from baseline in insulin sensitivity/resistance index after 12-week treatment

    Time frame: baseline to 12 weeks

    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 outcomes

  1. change from baseline in beta-cell function after 12-week treatment

    Time frame: baseline to 12 weeks

    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

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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