NCT04088461

Brief Summary

The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 11, 2019

Last Update Submit

September 11, 2019

Conditions

Prediabetic StateImpaired Glucose ToleranceInsulin Resistance

Keywords

PrediabetesInsulin resistancehyperglucemia

Outcome Measures

Primary Outcomes (2)

  • Glucose levels during OGTT

    Glucose levels during OGTT

    6 months

  • Pancreatic beta cell function

    Pancreatic beta cell function measured with the disposition index during OGTT

    6 months

Study Arms (2)

Linagliptin + Metformin and lifestyle

EXPERIMENTAL

Patients with impaired glucose tolerance randomly assigned to linagliptin 2.5 mg + metftormin 850 mg every 12 hours during 6 months.

Drug: Linagliptin / Metformin Oral Tablet

Metformin

ACTIVE COMPARATOR

Patients with impaired glucose tolerance randomly assigned to metftormin 850 mg every 12 hours during 6 months.

Drug: Metformin

Interventions

Linagliptin / Metformin Oral TabletDRUG

Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program

Also known as: Combined treatment
Linagliptin + Metformin and lifestyle
MetforminDRUG

Metformin 850 mg twice daily plus lifestyle modifications program

Also known as: Metformin alone
Metformin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.
  • Patients who accept to participate in the study and sign informed consent.

You may not qualify if:

  • Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT
  • Serum creatinine \> 1.6 mg/dL
  • Hypertriglyceridemia very high (\>500 mg/dL)
  • Pregnancy
  • Systolic blood pressure \> 180 mmHg or Diastolic blood pressure \>105 mmHg (patients could be re-screened after blood pressure control)
  • Excessive alcohol intake, acute or chronic
  • Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing's syndrom, Thyrotoxicosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Guanajuato

León, Guanajuato, 37670, Mexico

Location

Related Publications (1)

  • Alvarez-Canales MFL, Salazar-Lopez SS, Farfan-Vazquez D, Martinez-Lopez YE, Gonzalez-Mena JN, Jimenez-Ceja LM, Vargas-Ortiz K, Evia-Viscarra ML, Montes de Oca-Loyola ML, Folli F, Aguilar-Garcia A, Guardado-Mendoza R. Effect of linagliptin on glucose metabolism and pancreatic beta cell function in patients with persistent prediabetes after metformin and lifestyle. Sci Rep. 2021 Apr 22;11(1):8750. doi: 10.1038/s41598-021-88108-8.

    PMID: 33888772DERIVED

MeSH Terms

Conditions

Prediabetic StateGlucose IntoleranceInsulin Resistance

Interventions

LinagliptinMetforminCombined Modality Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaHyperinsulinism

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolinesBiguanidesGuanidinesAmidinesOrganic ChemicalsTherapeutics

Study Officials

  • Rodolfo Guardado Mendoza, MDPhD

    Universidad de Guanajuato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)