Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Linagliptin

• Registration Number: NCT01897532
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Study Start: 2013-07-10
• Study First Posted: 2013-07-12
• Primary Completion: 2018-01-18
• Study Completion: 2018-01-18
• Results First Submitted: 2018-12-21
• Results First Submitted QC: 2018-12-21
• Results First Posted: 2019-01-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6991

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Linagliptin	Linagliptin	-

Primary Outcome Measures

Name	Time	Method
Time to the First Occurrence of Any of the Following Adjudication-confirmed Components of the Primary Composite Endpoint 3-point Major Adverse Cardiovascular (CV) Events (3-point MACE): CV Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke.	From randomization to individual end of observation; up to 4.3 years	Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.

Secondary Outcome Measures

Name	Time	Method
Time to the First Occurrence of Any of the Following Adjudication-confirmed Components: Renal Death, Sustained End Stage Renal Disease (ESRD), or Sustained Decrease of 40% or More in Estimated Glomerular Filtration Rate (eGFR).	From randomization to individual end of observation; up to 4.3 years	Time to the first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR.; The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR was reported.

Trial Locations

Locations (636)

Longwood Research; 🇺🇸 Huntsville, Alabama, United States

Scottsboro Quick Care Clinic; 🇺🇸 Scottsboro, Alabama, United States

Office of Dr. Terence T. Hart MD; 🇺🇸 Tuscumbia, Alabama, United States

Arrowhead Health Centers; 🇺🇸 Glendale, Arizona, United States

Precision Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Harrisburg Family Medical Center; 🇺🇸 Harrisburg, Arkansas, United States

Cardiology and Medicine Clinic; 🇺🇸 Little Rock, Arkansas, United States

Little Rock Diagnostic Clinic; 🇺🇸 Little Rock, Arkansas, United States

Kaiser Permanente - San Diego, Bonita; 🇺🇸 Bonita, California, United States

John Muir Physician Network Clinical Research Center; 🇺🇸 Concord, California, United States

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