WHO ICTRP trial
CAROLINA: Cardiovascular Outcome Study of Linagliptin versus Glimepiride in…
EUCTR2009-013157-15-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-013157-15-GB |
|---|---|
| Public title | CAROLINA: Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Patients With Type 2 Diabetes |
| Scientific 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. The CAROLINA Trial. - CAROLINA |
| Primary sponsor | Boehringer Ingelheim Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Serbia;Portugal;United States;Philippines;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South… |
| Conditions | Patients with documented diagnosis of T2DM with insufficient glycaemic control and at high risk of CV events prior to informed consent can be enrolled in the study. MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II… |
| Interventions | Trade Name: Trajenta Product Name: linagliptin Product Code: BI1356 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: linagliptin CAS Number: 668270-12-0 Current Sponsor code: BI 1356 Concentration unit: mg milligram(s)… |
| Registration date | Sep 11, 2010 |
| Target size | 6000 |
| Secondary IDs | 1218.74;2009-013157-15-BE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: