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OpenTrials
Completed

NCT Number: NCT01204294

Comprehensive Add on Study in Japan

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.78.008 Boehringer Ingelheim Investigational Site, Akishima, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
  • Impaired hepatic function
  • 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
  • Treatment with anti-obesity drugs

Treatment and study plan

Linagliptin

Drug

Linagliptin once daily

metformin

Drug

Metformin twice or three time per day

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: The first drug administration through 7 days after the last drug administration, up to 382 days

    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

Secondary outcomes

  1. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: Baseline and 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 17, 2010
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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