Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Boehringer Ingelheim857 enrolled

Overview

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

857

Conditions

Diabetes Mellitus, Type 2

Interventions

BI 1356DRUG

BI 1356 high dose tablet, once daily

BI 1356 + metforminDRUG

BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily

Bi 1356 + metforminDRUG

BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm Exclusion criteria: Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass

Locations (138)

Outcomes

Primary Outcomes

HbA1c Change From Baseline at Week 24

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Time frame: Baseline and week 24

Secondary Outcomes

HbA1c Change From Baseline at Week 6

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Time frame: Baseline and week 6

HbA1c Change From Baseline at Week 12

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Time frame: Baseline and week 12

HbA1c Change From Baseline at Week 18

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Time frame: Baseline and week 18

FPG Change From Baseline at Week 24

This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Time frame: Baseline and week 24

FPG Change From Baseline at Week 2

This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Data from ClinicalTrials.gov

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Metformin 500 mg tablet, twice daily

metforminDRUG

metformin 1000 mg tablet, twice daily

matching placeboDRUG

matching placebo

1218.46.11005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

1218.46.11003 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1218.46.11002 Boehringer Ingelheim Investigational Site

Red Deer, Alberta, Canada

1218.46.11006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1218.46.11008 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

1218.46.11004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1218.46.11007 Boehringer Ingelheim Investigational Site

Oakville, Ontario, Canada

1218.46.11009 Boehringer Ingelheim Investigational Site

Oshawa, Ontario, Canada

1218.46.11010 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1218.46.38502 Boehringer Ingelheim Investigational Site

Karlovac, Croatia

...and 128 more locations

Time frame: Baseline and week 2

FPG Change From Baseline at Week 6

This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Time frame: Baseline and week 6

FPG Change From Baseline at Week 12

This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Time frame: Baseline and week 12

FPG Change From Baseline at Week 18

This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Time frame: Baseline and week 18

Percentage of Patients With HbA1c <7.0% at Week 24

The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.

Time frame: Baseline and Week 24

Percentage of Patients With HbA1c<7.0 at Week 24

Time frame: Baseline and Week 24

Percentage of Patients With HbA1c <6.5% at Week 24

The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\< 6.5%

Time frame: Baseline and Week 24

Percentage of Patients With HbA1c < 6.5% at Week 24

Time frame: Baseline and Week 24

Percentage of Patients With HbA1c Lowering by 0.5% at Week 24

The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.

Time frame: Baseline and week 24

Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24

This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.

Time frame: Baseline and week 24

HbA1c Change From Baseline at Week 24 for Open-label Patients

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.

Time frame: Baseline and week 24

FPG Change From Baseline at Week 24 for Open-label Patients

This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.

Time frame: Baseline and week 24

Use of Rescue Therapy

The use of rescue therapy (SUs, thiazolidinediones \[TZDs\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.

Time frame: 24 weeks