CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01243424
First received: November 17, 2010
Last updated: October 7, 2014
Last verified: October 2014

November 17, 2010
October 7, 2014
October 2010
September 2018   (final data collection date for primary outcome measure)
Time to first occurence of any of the following adjudicated components of the primary composite endpoint: CV death, non-fatal MI (excluding silent MI), non-fatal stroke and hospitalisation for unstable angina pectoris [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
Time to first occurence of any of the following components of the primary composite endpoint: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina pectoris [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01243424 on ClinicalTrials.gov Archive Site
  • Time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI) [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients on study treatment at study end, that at Final Visit maintain glycemic control (HbA1c <= 7.0%) without need for rescue medication, without any moderate/severe hypoglycaemic episodes and without > 2% weight gain (from V6 on) [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Occurence of any of the adjudicated components of the composite primary and composite first key secondary endpoint. [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Transitions in albuminuria classes between baseline and Final visit. [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients on study treatment at study end, that at Final Visit maintain glycaemic control (HbA1c <= 7.0%) without need for rescue medication and without > 2% weight gain (from V6 on) [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Occurence of and time to composite endpoint of all CEC confirmed adjudicated events [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Final Visit in diabetes related laboratory parameters: HbA1c, fasting plasma glucose, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides, Creatinine, eGFR (MDRD formula), Albumin [ Time Frame: 400 weeks ] [ Designated as safety issue: No ]
  • Composite endpoint of (proportion of patients on study treatment at study end, maintain glycemic control (HbA1c =< 7%) without need of rescue medication and without moderate/severe hypoglycemic episodes and without => 2% weight gain at final visit [ Designated as safety issue: No ]
  • Composite endpoint of (proportion of patients on study treatment at study end, maintain glycemic control (HbA1c =< 7%) without need of rescue medication and without => 2% weight gain at final visit [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: linagliptin
    linagliptin tablets 5mg QD
  • Drug: glimepiride
    glimepiride over-encapsulated tablet 1-4 mg QD
  • Drug: linagliptin placebo
    linagliptin placebo
  • Drug: glimepride placebo
    glimepiride placebo
  • Experimental: linagliptin
    patient to receive linagliptin or glimepiride placebo overencapsulated tablet QD
    Interventions:
    • Drug: linagliptin
    • Drug: glimepride placebo
  • Active Comparator: glimepiride 1-4 mg QD
    patient to receive glimepiride 1-4 mg or linagliptin placebo tablet QD
    Interventions:
    • Drug: glimepiride
    • Drug: linagliptin placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6000
September 2018
September 2018   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Type 2 diabetes
  2. Elevated glycosylated heamoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
  3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor

Exclusion criteria:

  1. Type 1 diabetes
  2. Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
  3. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Tunisia,   South Africa,   Greece,   Netherlands,   Belgium,   France,   Spain,   Portugal,   Ireland,   Finland,   Bulgaria,   Hungary,   Ukraine,   Serbia,   Italy,   Romania,   Switzerland,   Czech Republic,   Slovakia,   United Kingdom,   Sweden,   Norway,   Germany,   Peru,   Mexico,   Argentina,   Brazil,   Chile,   Colombia,   Malaysia,   Australia,   Philippines,   New Zealand,   Russian Federation,   Japan,   Korea, Republic of,   Hong Kong,   Taiwan,   India,   Israel,   Georgia
 
NCT01243424
1218.74, 2009-013157-15
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2014

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