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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Linagliptin
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 574
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bigu+Lina
biguanide plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: Glin+Lina
glinide plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: Glit+Lina
glitazone plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: SU+Lina
sulfonylurea plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Active Comparator: SU+Met
sulfonylurea plus metformin
Drug: Metformin
Metformin twice or three time per day
Active Comparator: A-GI+Met
alpha-glucosidase inhibitor plus metformin
Drug: Metformin
Metformin twice or three time per day

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204294

Locations
Japan
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
1218.78.013 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1218.78.009 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
1218.78.043 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki, Japan
1218.78.019 Boehringer Ingelheim Investigational Site
Isesaki, Gunma, Japan
1218.78.036 Boehringer Ingelheim Investigational Site
Kashiwara, Osaka, Japan
1218.78.026 Boehringer Ingelheim Investigational Site
Kasugai, Aichi, Japan
1218.78.038 Boehringer Ingelheim Investigational Site
Kawachinagano, Osaka, Japan
1218.78.021 Boehringer Ingelheim Investigational Site
Kitaazumi-gun, Nagano, Japan
1218.78.033 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, Japan
1218.78.022 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, Japan
1218.78.012 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo, Japan
1218.78.041 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo, Japan
1218.78.035 Boehringer Ingelheim Investigational Site
Morioka, Iwate, Japan
1218.78.034 Boehringer Ingelheim Investigational Site
Morioka, Iwate, Japan
1218.78.018 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki, Japan
1218.78.024 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1218.78.031 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1218.78.027 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1218.78.028 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1218.78.025 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1218.78.039 Boehringer Ingelheim Investigational Site
Oita, Oita, Japan
1218.78.004 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa, Japan
1218.78.016 Boehringer Ingelheim Investigational Site
Sagae, Yamagata, Japan
1218.78.020 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1218.78.001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1218.78.042 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1218.78.005 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa, Japan
1218.78.014 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1218.78.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku. Tokyo, Japan
1218.78.011 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka, Japan
1218.78.003 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1218.78.029 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama, Japan
1218.78.023 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama, Japan
1218.78.010 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki, Japan
1218.78.015 Boehringer Ingelheim Investigational Site
Yamagata, Yamagata, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01204294     History of Changes
Other Study ID Numbers: 1218.78
Study First Received: September 16, 2010
Results First Received: December 18, 2012
Last Updated: February 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014