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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00622284
First received: February 13, 2008
Last updated: December 11, 2013
Last verified: December 2013

February 13, 2008
December 11, 2013
February 2008
December 2010   (final data collection date for primary outcome measure)
  • HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.
  • HbA1c Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.
The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks). [ Time Frame: 104 weeks ]
Complete list of historical versions of study NCT00622284 on ClinicalTrials.gov Archive Site
  • Body Weight Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.
  • Body Weight Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.
  • Incidence of Hypoglycaemic Events up to 52 Weeks [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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)
  • Incidence of Hypoglycaemic Events up to 104 Weeks [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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)
  • Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
    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.
  • Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Patients With HbA1c <7.0% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Patients With HbA1c <7.0% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Patients With HbA1c <6.5% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Patients With HbA1c <6.5% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104
  • 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.
  • HbA1c Change at Week 4 [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
    Difference of base percent value [Week x(%) - baseline (%)]
  • HbA1c Change at Week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 12 [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 16 [ Time Frame: Baseline and week 16 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 28 [ Time Frame: Baseline and week 28 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 40 [ Time Frame: Baseline and week 40 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 52 [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 65 [ Time Frame: Baseline and week 65 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 78 [ Time Frame: Baseline and week 78 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 91 [ Time Frame: Baseline and week 91 ] [ Designated as safety issue: No ]
  • HbA1c Change at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
    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.
  • Change in Baseline Lipid Parameter Cholesterol at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter HDL at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
  • Change in Baseline Lipid Parameter Triglyceride at Week 104 [ Time Frame: Baseline and week 104 ] [ Designated as safety issue: No ]
Key secondary endpoint for regulatory purpose is the change from baseline in HbA1c after 52 wks of treatment Change from baseline in FPG after 52 and 104 weeks of treatment [ Time Frame: 52 and 104 Weeks ]
Not Provided
Not Provided
 
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Placebo identical to BI 1356 5mg
    Placebo tablet once daily
  • 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
  • Drug: Glimepiride
    1mg or 2mg or 3mg or 4mg in the morning for 104 weeks
  • 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
    Interventions:
    • Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
    • Drug: BI 1356
  • 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)
    Interventions:
    • Drug: Placebo identical to BI 1356 5mg
    • Drug: Glimepiride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1560
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa,   Netherlands,   France,   Bulgaria,   Ireland,   Hungary,   Italy,   United Kingdom,   Denmark,   Sweden,   Norway,   Poland,   Germany,   Hong Kong,   India
 
NCT00622284
1218.20, 2007-004585-40
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP