Japanese P III vs Voglibose and Placebo
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| ClinicalTrials.gov Identifier: NCT00654381 |
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Recruitment Status :
Completed
First Posted : April 8, 2008
Results First Posted : August 2, 2011
Last Update Posted : January 27, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
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Brief Summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | Drug: BI 1356 Drug: voglibose placebo Drug: BI 1356 placebo Drug: voglibose | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 561 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | January 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information available for:
Linagliptin
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: voglibose 0.2 mg three times a day (TID)
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
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Drug: voglibose
0.6 mg/daily |
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Experimental: BI 1356 low dose
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
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Drug: BI 1356
5 mg/daily |
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Experimental: BI 1356 high dose
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
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Drug: BI 1356
10 mg/daily |
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Placebo Comparator: placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
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Drug: voglibose placebo
three times daily Drug: BI 1356 placebo once daily |
Primary Outcome Measures :
- Change From Baseline in HbA1c at Week 12 [ Time Frame: 12 weeks ]Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
- Change From Baseline in HbA1c at Week 26 [ Time Frame: 26 weeks ]Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
- Examination of Long-term Safety of Linagliptin (52-week Treatment) [ Time Frame: 52 weeks ]The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Secondary Outcome Measures :
- Relative Efficacy Response of HbA1c at Week 12 [ Time Frame: 12 weeks ]HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
- Relative Efficacy Response of HbA1c at Week 26 [ Time Frame: 26 weeks ]HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
- Relative Efficacy Response of HbA1c at Week 52 [ Time Frame: 52 weeks ]HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: 12 weeks ]Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: 26 weeks ]Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: 52 weeks ]Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
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| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
- Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
- Age: >= 20 and <= 80
- Body Mass Index (BMI) <= 40 kg/m2
Exclusion criteria:
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
- Impaired hepatic function
- History of severe allergy/hypersensitivity
- Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
- Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654381
Locations
Show 47 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00654381 |
| Other Study ID Numbers: |
1218.23 |
| First Posted: | April 8, 2008 Key Record Dates |
| Results First Posted: | August 2, 2011 |
| Last Update Posted: | January 27, 2014 |
| Last Verified: | December 2013 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Inositol Linagliptin Voglibose Hypoglycemic Agents Physiological Effects of Drugs Incretins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glycoside Hydrolase Inhibitors Vitamin B Complex Vitamins Micronutrients |