CARMELINA: Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus at High Vascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01897532
First received: July 9, 2013
Last updated: July 23, 2014
Last verified: July 2014

July 9, 2013
July 23, 2014
July 2013
January 2018   (final data collection date for primary outcome measure)
Time to the first occurence of any of the following adjudicated components of the primary composite endpoint (4-point MACE): CV death, non-fatal MI, non fatal stroke and hospitalization for unstable angina pectoris [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01897532 on ClinicalTrials.gov Archive Site
  • Time to first occurence of any of the following adjudicated components: CV death, non fatal MI and non fatal stroke (3-point MACE) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Time to first occurence of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in eGFR [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Time to first occurance of any of the following adjudicated components: CV death, non fatal MI and non fatal stroke (3-point MACE) [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Time to first occurance of any of the following adjudicated composite renal endpoint: renal death, end stage renal disease and a sustained decrease of 50% or more in eGFR [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CARMELINA: Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus at High Vascular Risk
CARMELINA: A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk

CARMELINA is a randomized, double-blind, placebo controlled, parallel group study and compares treatment with linagliptin (5 mg once daily) to treatment with placebo (matching tablets once daily) as add-on therapy to standard of care.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    placebo matching tablets
  • Drug: Linagliptin
  • Experimental: Linagliptin
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8300
January 2018
January 2018   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Documented diagnosis of T2DM before visit 1(screening).
  2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if => consecutive 7 days.
  3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization.
  4. HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)
  5. Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
  6. Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
  7. Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure
  8. High risk of CV events defined by: 1) albuminuria (micro or macro) and previous macrovascular disease and/or 2) impaired renal function with predefined UACR

Exclusion criteria:

  1. Type 1 diabetes mellitus.
  2. Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient.
  3. Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.
  4. eGFR <15 ml/min (severe renal impairment or ESRD, MDRD formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis.
  5. Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve).
  6. Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent
Both
18 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
United States,   Argentina,   Bulgaria,   Canada,   Chile,   Croatia,   Czech Republic,   Hungary,   Israel,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom
 
NCT01897532
1218.22, 2011-004148-23
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP