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CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01243424
First received: November 17, 2010
Last updated: April 19, 2017
Last verified: April 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: linagliptin Drug: glimepiride Drug: linagliptin placebo Drug: glimepride placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Time to first occurrence of any of the following adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) or non-fatal stroke [ Time Frame: 432 weeks ]
Secondary Outcome Measures:
- Time to first occurrence of any of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke or hospitalisation for unstable angina pectoris [ Time Frame: 432 weeks ]
- 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: 432 weeks ]
- Occurence of any of the adjudicated components of the composite primary and composite first key secondary endpoint. [ Time Frame: 432 weeks ]
- Transitions in albuminuria classes between baseline and Final visit. [ Time Frame: 432 weeks ]
- 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: 432 weeks ]
- Occurence of and time to composite endpoint of all CEC confirmed adjudicated events [ Time Frame: 432 weeks ]
- 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), Urinary Albumin [ Time Frame: 432 weeks ]
| Enrollment: | 6072 |
| Actual Study Start Date: | October 26, 2010 |
| Estimated Study Completion Date: | March 1, 2019 |
| Estimated Primary Completion Date: | February 1, 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: linagliptin
patient to receive linagliptin or glimepiride placebo overencapsulated tablet QD
|
Drug: linagliptin
linagliptin tablets 5mg QD
Drug: glimepride placebo
glimepiride placebo
|
|
Active Comparator: glimepiride 1-4 mg QD
patient to receive glimepiride 1-4 mg or linagliptin placebo tablet QD
|
Drug: glimepiride
glimepiride over-encapsulated tablet 1-4 mg QD
Drug: linagliptin placebo
linagliptin placebo
|
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Type 2 diabetes
- Elevated glycosylated haemoglobin (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)
- Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
- BMI =< 45kg/m²
- age between >= 40 and =< 85 years
- signed and dated written ICF
- stable anti-diabetic background for at least 8 wks before study start
Exclusion criteria:
- Type 1 diabetes
- 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)
- treatment with any anti-obesity drug less than 3 months before ICF
- uncontrolled hyperglycemia
- previous or planned bariatric surgery or intervention
- current or planned system corticoid treatment
- change in thyroid hormones treatment
- acute liver disease or impaired hepatic function
- pre-planned coronary artery revascularization within 6 months of ICF
- known hypersensitivity to any of the components
- Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
- congestive heart failure class III or IV
- acute or chronic metabolic acidosis
- hereditary galactose intolerance
- alcohol or drug abuse
- participation in another trail with IMP given 2 months before IMP start
- pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
- patients considered reliable by the investigator
- acute coronary syndrome =< 6 wks before ICF
- stroke or TIA =< 3 months prior to ICF
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01243424
Show 612 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243424
Show 612 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01243424 History of Changes |
| Other Study ID Numbers: |
1218.74 2009-013157-15 ( EudraCT Number: EudraCT ) |
| Study First Received: | November 17, 2010 |
| Last Updated: | April 19, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Linagliptin Hypoglycemic Agents Physiological Effects of Drugs Incretins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 23, 2017