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

Boehringer Ingelheim1,560 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,560

Conditions

Diabetes Mellitus, Type 2

Interventions

Placebo identical to BI 1356 5mgDRUG

Placebo tablet once daily

Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mgDRUG

Placebo tablets once daily

BI 1356DRUG

5mg, once daily in the morning for 104 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (221)

Outcomes

Primary Outcomes

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 52

HbA1c Change From Baseline at 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.

Time frame: Baseline and week 104

Secondary Outcomes

Body Weight Change From Baseline at 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.

Time frame: Baseline and week 52

Body Weight Change From Baseline at 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.

Time frame: Baseline and week 104

Incidence of Hypoglycaemic Events up to 52 Weeks

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)

Time frame: Week 52

Incidence of Hypoglycaemic Events up to 104 Weeks

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)

Data from ClinicalTrials.gov

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

1218.20.10033 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

1218.20.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

1218.20.10020 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1218.20.10035 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1218.20.10037 Boehringer Ingelheim Investigational Site

Los Gatos, California, United States

1218.20.10034 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

1218.20.10023 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

1218.20.10030 Boehringer Ingelheim Investigational Site

Topeka, Kansas, United States

1218.20.10028 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1218.20.10006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

...and 211 more locations

Time frame: Week 104

Fasting Plasma Glucose (FPG) Change From Baseline at 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.

Time frame: Baseline and week 52

Fasting Plasma Glucose (FPG) Change From Baseline at 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.

Time frame: Baseline and week 104

Percentage of Patients With HbA1c <7.0% at 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.

Time frame: Week 52

Percentage of Patients With HbA1c <7.0% at 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.

Time frame: Week 104

Percentage of Patients With HbA1c <6.5% at 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.

Time frame: Week 52

Percentage of Patients With HbA1c <6.5% at 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.

Time frame: Week 104

Percentage of Patients With HbA1c Lowering by 0.5% at Week 104

Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104

Time frame: Week 104

2 hr Postprandial Glucose (PPG) Change From Baseline at 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.

Time frame: Baseline and week 104

HbA1c Change at Week 4

Difference of base percent value \[Week x(%) - baseline (%)\]

Time frame: Baseline and week 4

HbA1c Change at Week 8

Time frame: Baseline and week 8

HbA1c Change at Week 12

Time frame: Baseline and week 12

HbA1c Change at Week 16

Time frame: Baseline and week 16

HbA1c Change at Week 28

Time frame: Baseline and week 28

HbA1c Change at Week 40

Time frame: Baseline and week 40

HbA1c Change at Week 52

Time frame: Baseline and week 52

HbA1c Change at Week 65

Time frame: Baseline and week 65

HbA1c Change at Week 78

Time frame: Baseline and week 78

HbA1c Change at Week 91

Time frame: Baseline and week 91

HbA1c Change at 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.

Time frame: Baseline and week 104

Change in Baseline Lipid Parameter Cholesterol at Week 104

Time frame: Baseline and week 104

Change in Baseline Lipid Parameter HDL at Week 104

Time frame: Baseline and week 104

Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104

Time frame: Baseline and week 104

Change in Baseline Lipid Parameter Triglyceride at Week 104

Time frame: Baseline and week 104