Comprehensive Add on Study in Japan
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01204294
First received: September 16, 2010
Last updated: January 29, 2013
Last verified: January 2013
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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 Pharmaceuticals:
Primary Outcome Measures:
- Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ] [ 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:
- 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
Contacts and Locations
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 | |
| 1218.78.040 Boehringer Ingelheim Investigational Site | |
| Fukuoka, Fukuoka, Japan | |
| 1218.78.032 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 | |
| 1218.78.042 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1218.78.001 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1218.78.020 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 Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| 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: | January 29, 2013 |
| 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 BI 1356 Hypoglycemic Agents |
Metformin Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013