Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01703286
First received: October 1, 2012
Last updated: January 22, 2014
Last verified: January 2014

October 1, 2012
January 22, 2014
October 2012
January 2014   (final data collection date for primary outcome measure)
Change from baseline in endothelial function as measured with flow mediated vasodilation (FMD) at baseline (fasting), and on day 28 (fasting) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01703286 on ClinicalTrials.gov Archive Site
  • Change from baseline in endothelial independent vasodilation (EIDV) at baseline (2 h post meal), and on day 28 (2 h post meal) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in endothelial function as measured with flow mediated vasodilation (FMD) at baseline (2 h post meal), and on day 28 (2 h post meal) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with hepatic injury [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with hypersensitivity reactions [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with skin lesions [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with renal adverse events [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with Pancreatitis [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in endothelial independent vasodilation (EIDV) at baseline (fasting), and on day 28 (fasting) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 25 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial to Assess the Influence of 4 Weeks' Treatment With Linagliptin as Compared to Glimepiride and Placebo on Endothelial Function in Patients With Type 2 Diabetes Using FMD (Flow-Mediated Vasodilation)
Randomized, Three Period Cross Over, Double Blind, Double Dummy Study in Type 2 Diabetic Patients to Assess the Endothelial Effects of Linagliptin, Glimepiride and Placebo Therapy for 28 Days ('ENDOTHELINA')

The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.

Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo
    Placebo matching Glimepiride
  • Drug: Linagliptin
    given once daily for 28 days
  • Drug: Placebo
    Placebo matching Linagliptin
  • Drug: Glimepiride
    1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
  • Experimental: Linagliptin 5mg
    given once daily over 28 days
    Interventions:
    • Drug: Placebo
    • Drug: Linagliptin
  • Active Comparator: Glimepiride
    given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days
    Interventions:
    • Drug: Placebo
    • Drug: Glimepiride
  • Placebo Comparator: Placebo
    given once daily over 28 days
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Type 2 diabetic male and female patients according to the following criteria:

    Based upon a complete medical history and clinical laboratory tests

  2. Age >= 18 and Age <= 65 years
  3. Body mass index >= 25 <= 35 kg/m2
  4. HbA1c <= 7.5%
  5. Treatment with metformin (=1500 mg daily) for <= 3 months
  6. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

    For female patients of childbearing potential:

  7. Use of acceptable method of contraception (Pearl-Index <1).

Exclusion criteria:

  1. Treatment with any glucose-lowering drug except for metformin within prior 3 months.
  2. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
  3. Any evidence of a clinically relevant acute concomitant disease
  4. History of cardiovascular disease (e.g. coronary artery disease history of acute myocard infarction or stroke, peripheral vascular disease).
  5. History of major diabetic complications (e.g. nephropathy, retinopathy)
  6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, immunological or hormonal disorders (except: hypertension treated with angiotensin receptor blocker or angiotensin-converting-enzyme inhibitors, hyperlipidemia with statin therapy, thyroid hormone replacement therapy, all stable for at least three months prior to screening).
  7. Surgery of the gastrointestinal tract (except appendectomy).
  8. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  9. History of relevant orthostatic hypotension, fainting spells or blackouts.
  10. Chronic or relevant acute infections.
  11. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
  12. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
  13. Participation in another trial with an investigational drug within one month prior to administration or during the trial.
  14. Smoker (>= 1 cigarettes or >= 1 cigars or >= 1 pipes/day).
  15. Alcohol abuse (more than 60 g/day).
  16. Drug abuse.
  17. Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
  18. Excessive physical activities (within one week prior to administration or during the trial).
  19. Any laboratory value outside the reference range that is of clinical relevance.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01703286
1218.105, 2012-003317-33
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2014

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