Comprehensive Add on Study in Japan

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01204294
First received: September 16, 2010
Last updated: February 27, 2014
Last verified: February 2014

September 16, 2010
February 27, 2014
September 2010
January 2012   (final data collection date for primary outcome measure)
Incidence of Adverse Events (AEs) [ Time Frame: The first drug administration through 7 days after the last drug administration, up to 382 days ] [ Designated as safety issue: Yes ]
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
  • Incidence and intensity of adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Withdrawal due to adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Hhypoglycaemic events [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Findings in vital signs and 12-lead electrocardiograms [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01204294 on ClinicalTrials.gov Archive Site
Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
Change from baseline in HbA1c after 52 weeks of treatment [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comprehensive Add on Study in Japan
An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Linagliptin
    Linagliptin once daily
  • Drug: Metformin
    Metformin twice or three time per day
  • Experimental: Bigu+Lina
    biguanide plus linagliptin
    Intervention: Drug: Linagliptin
  • Experimental: Glin+Lina
    glinide plus linagliptin
    Intervention: Drug: Linagliptin
  • Experimental: Glit+Lina
    glitazone plus linagliptin
    Intervention: Drug: Linagliptin
  • Experimental: SU+Lina
    sulfonylurea plus linagliptin
    Intervention: Drug: Linagliptin
  • Experimental: A-GI+Lina
    alpha-glucosidase inhibitor plus linagliptin
    Intervention: Drug: Linagliptin
  • Active Comparator: SU+Met
    sulfonylurea plus metformin
    Intervention: Drug: Metformin
  • Active Comparator: A-GI+Met
    alpha-glucosidase inhibitor plus metformin
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
574
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus
  2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

  1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
  2. Impaired hepatic function
  3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
  4. Treatment with anti-obesity drugs
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01204294
1218.78
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Eli Lilly and Company
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

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