Comprehensive Add on Study in Japan

Phase 3CompletedNCT01204294

Boehringer Ingelheim574 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

574

Conditions

Diabetes Mellitus, Type 2

Interventions

LinagliptinDRUG

Linagliptin once daily

LinagliptinDRUG

Linagliptin once daily

MetforminDRUG

Metformin twice or three time per day

Metformin

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

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

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

Secondary Outcomes

Glycosylated Haemoglobin A1c (HbA1c)

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.

Time frame: Baseline and 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

1218.78.008 Boehringer Ingelheim Investigational Site

Akishima, Tokyo, Japan

1218.78.030 Boehringer Ingelheim Investigational Site

Amagasaki, Hyogo, Japan

1218.78.017 Boehringer Ingelheim Investigational Site

Annaka, Gunma, Japan

1218.78.006 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

1218.78.007 Boehringer Ingelheim Investigational Site

Aomori, Aomori, Japan

1218.78.009 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

1218.78.013 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

1218.78.032 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

1218.78.040 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

1218.78.037 Boehringer Ingelheim Investigational Site

Higashi Osaka, Osaka, Japan

...and 33 more locations