A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Boehringer Ingelheim227 enrolled

Overview

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

227

Conditions

Diabetes Mellitus, Type 2

Interventions

LinagliptinDRUG

5mg once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication) Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance

Locations (53)

1218.50.10009 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1218.50.10011 Boehringer Ingelheim Investigational Site

Peoria, Arizona, United States

1218.50.10013 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

1218.50.10016 Boehringer Ingelheim Investigational Site

Harbor City, California, United States

1218.50.10017 Boehringer Ingelheim Investigational Site

Huntington Park, California, United States

Outcomes

Primary Outcomes

HbA1c Change From Baseline at Week 18 (Interim Analysis)

Time frame: Baseline and week 18

HbA1c Change From Baseline at Week 18 (Final Analysis)

HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.

Time frame: Baseline and week 18

Secondary Outcomes

Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)

This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).

Time frame: Baseline and week 18

Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

Time frame: Week 18

Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

Time frame: Week 18

Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)

Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.

Time frame: Week 18

The Change in HbA1c From Baseline by Visit Over Time

HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.

Time frame: Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52

The Change in FPG From Baseline by Visit Over Time

This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.

Time frame: Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52