Comprehensive Add on Study in Japan

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204294

1218.78

Details and patient eligibility

About

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.

Enrollment: 574 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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574 participants in 7 patient groups

Bigu+Lina

Experimental group

Description:

biguanide plus linagliptin

Treatment:

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Glin+Lina

Experimental group

Description:

glinide plus linagliptin

Treatment:

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Glit+Lina

Experimental group

Description:

glitazone plus linagliptin

Treatment:

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

SU+Lina

Experimental group

Description:

sulfonylurea plus linagliptin

Treatment:

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

A-GI+Lina

Experimental group

Description:

alpha-glucosidase inhibitor plus linagliptin

Treatment:

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

Drug: Linagliptin

SU+Met

Active Comparator group

Description:

sulfonylurea plus metformin

Treatment:

Drug: Metformin

Drug: Metformin

A-GI+Met

Active Comparator group

Description:

alpha-glucosidase inhibitor plus metformin

Treatment:

Drug: Metformin

Drug: Metformin