Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus

NCT05290506 | Completed Phase 3

• 1 other identifier: Linagliptin study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Type 2 Diabetes

Keywords

glucagon-like peptide 1; Dipeptidyl peptidase inhibitor; oral glucose tolerance test; prediabetes; type 2 diabetes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

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

  baseline to 12 weeks

Study Arms (4)

Prediabetes Low GLP-1

ACTIVE COMPARATOR

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.

Drug: Dipeptidyl-Peptidase IV Inhibitors

Prediabetes High GLP-1

ACTIVE COMPARATOR

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.

Drug: Dipeptidyl-Peptidase IV Inhibitors

Diabetes Low GLP-1

ACTIVE COMPARATOR

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.

Drug: Dipeptidyl-Peptidase IV Inhibitors

Diabetes High GLP-1

ACTIVE COMPARATOR

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.

Drug: Dipeptidyl-Peptidase IV Inhibitors

Interventions

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

Also known as: linagliptin

Diabetes High GLP-1; Diabetes Low GLP-1; Prediabetes High GLP-1; Prediabetes Low GLP-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Sultan Ismail

Johor Bahru, Johor, 81100, Malaysia

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• SHIAU CHONG

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs, principal investigator

Model Details: open-labelled, single treatment study between Low GLP-1 group and High GLP-1 group of prediabetes/type 2 diabetes

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 22, 2022
• Study Start: August 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)