Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00800683
First received: December 1, 2008
Last updated: May 15, 2014
Last verified: May 2014

December 1, 2008
May 15, 2014
December 2008
January 2011   (final data collection date for primary outcome measure)
HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Safety and tolerability will be assessed in a descriptive way [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT00800683 on ClinicalTrials.gov Archive Site
  • HbA1c Change From Baseline at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • HbA1c Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
  • The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
  • The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
  • Percentage of Patients With HbA1c Lowering by 0.5% at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
  • FPG Change From Baseline at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]
    Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 36 [ Time Frame: Baseline and Week 36 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 42 [ Time Frame: Baseline and Week 42 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • FPG Change From Baseline at week52 [ 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 continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
  • Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
  • Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG [ Time Frame: first administration of randomised treatment to .... ] [ Designated as safety issue: No ]
    Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Change from baseline in HbA1c after 12 weeks treatment (Key secondary endpoint). Other HbA1c related parameters fasting Plasma Glucose, change in insulin and/ or sulphonylurea dosage at 52 weeks compared to baseline and over time [ Time Frame: 52 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 1356
    BI 1356 dosed once daily
  • Drug: placebo
    placebo matching BI 1356 taken once daily
  • Experimental: BI 1356
    patient to receive a tablet containing BI 1356 once daily
    Intervention: Drug: BI 1356
  • Placebo Comparator: placebo
    patient to receive a tablet identical to BI 1356 once daily
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
Not Provided
January 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
  • Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Unstable or acute congestive heart failure
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Hong Kong,   Israel,   New Zealand,   Ukraine
 
NCT00800683
1218.43, 2008-001569-27
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

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