Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

NCT01888796 | Terminated Phase 3 DMC

• 3 other identifiers: 12-0252012-003858-81EK 113/13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography. Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.

Conditions

Diabetes Mellitus Type 2 (T2DM); Left Ventricular Diastolic Dysfunction

Keywords

T2DM; diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular diastolic function

  Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrial (LA) volume

  baseline and 6 months

Secondary Outcomes (1)

• Change in serum NT-pro BNP levels

  baseline and 6 months

Study Arms (2)

Linagliptin

ACTIVE COMPARATOR

Linagliptin 5 mg (tablets) once daily for 6 month

Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

Placebo (tablets) once daily for 6 month

Drug: placebo

Interventions

Linagliptin DRUG

Also known as: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany

Linagliptin

placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus Type 2
• Age \> 50 years
• HbA1c \> 7%
• Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2
• Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist).
• Indication to increase anti-diabetic medication as judged by the investigator
• Written informed consent prior to study participation

You may not qualify if:

• Diabetes mellitus type 1
• Echocardiography:
• decreased left ventricular systolic function, ejection fraction (EF) \<45%
• regional wall motion abnormalities
• hypertrophic cardiomyopathy (septum \>15mm)
• severe valvular dysfunction
• Uncontrolled hypertension
• Atrial fibrillation
• Obstructive sleep apnea syndrome
• Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione
• Kidney disease CKD 4 and more (GFR \< 30 ml/min/1.73)
• Liver disease (ALT or AST \> 3 times the upper limit of norm) or known liver cirrhosis
• Active malignant disease
• HbA1c \> 8.5%
• Recent (\<3 months) clinically significant coronary or cerebral vascular event

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Internal Medicine I, University Hospital

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Ventricular Dysfunction, Left

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Nikolaus Marx, Univ.-Prof.

  Department of Internal Medicine I, RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 28, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 12, 2017

Record last verified: 2015-02

Locations

DE (1)