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Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622284
Recruitment Status : Completed
First Posted : February 25, 2008
Results First Posted : February 20, 2012
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Placebo identical to BI 1356 5mg Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg Drug: BI 1356 Drug: Glimepiride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Study Start Date : February 2008
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BI 1356 5mg, once daily
patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
 Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Placebo tablets once daily

Drug: BI 1356
5mg, once daily in the morning for 104 weeks
Active Comparator: Glimepiride
patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)
 Drug: Placebo identical to BI 1356 5mg
Placebo tablet once daily

Drug: Glimepiride
1mg or 2mg or 3mg or 4mg in the morning for 104 weeks


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
    This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

  2. HbA1c Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ]
    This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.


Secondary Outcome Measures :
  1. Body Weight Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
    This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

  2. Body Weight Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ]
    This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

  3. Incidence of Hypoglycaemic Events up to 52 Weeks [ Time Frame: Week 52 ]
    A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)

  4. Incidence of Hypoglycaemic Events up to 104 Weeks [ Time Frame: Week 104 ]
    A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)

  5. Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ]
    This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.

  6. Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ]
    This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.

  7. Percentage of Patients With HbA1c <7.0% at Week 52 [ Time Frame: Week 52 ]
    The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  8. Percentage of Patients With HbA1c <7.0% at Week 104 [ Time Frame: Week 104 ]
    The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  9. Percentage of Patients With HbA1c <6.5% at Week 52 [ Time Frame: Week 52 ]
    The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  10. Percentage of Patients With HbA1c <6.5% at Week 104 [ Time Frame: Week 104 ]
    The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

  11. Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 [ Time Frame: Week 104 ]
    Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104

  12. 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ]
    This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.

  13. HbA1c Change at Week 4 [ Time Frame: Baseline and week 4 ]
    Difference of base percent value [Week x(%) - baseline (%)]

  14. HbA1c Change at Week 8 [ Time Frame: Baseline and week 8 ]
  15. HbA1c Change at Week 12 [ Time Frame: Baseline and week 12 ]
  16. HbA1c Change at Week 16 [ Time Frame: Baseline and week 16 ]
  17. HbA1c Change at Week 28 [ Time Frame: Baseline and week 28 ]
  18. HbA1c Change at Week 40 [ Time Frame: Baseline and week 40 ]
  19. HbA1c Change at Week 52 [ Time Frame: Baseline and week 52 ]
  20. HbA1c Change at Week 65 [ Time Frame: Baseline and week 65 ]
  21. HbA1c Change at Week 78 [ Time Frame: Baseline and week 78 ]
  22. HbA1c Change at Week 91 [ Time Frame: Baseline and week 91 ]
  23. HbA1c Change at Week 104 [ Time Frame: Baseline and week 104 ]
    The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.

  24. Change in Baseline Lipid Parameter Cholesterol at Week 104 [ Time Frame: Baseline and week 104 ]
  25. Change in Baseline Lipid Parameter HDL at Week 104 [ Time Frame: Baseline and week 104 ]
  26. Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 [ Time Frame: Baseline and week 104 ]
  27. Change in Baseline Lipid Parameter Triglyceride at Week 104 [ Time Frame: Baseline and week 104 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
  2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
  3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
  4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA)
  2. Impaired hepatic function
  3. Renal failure or renal impairment
  4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
Contacts and Locations
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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): NCT00622284


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00622284    
Other Study ID Numbers: 1218.20
2007-004585-40 ( EudraCT Number: EudraCT )
First Posted: February 25, 2008    Key Record Dates
Results First Posted: February 20, 2012
Last Update Posted: January 29, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Linagliptin
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
 Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action