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OpenTrials
Completed

NCT Number: NCT00800683

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1218.43.61009 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 1356

Drug

BI 1356 dosed once daily

Placebo

Drug

placebo matching BI 1356 taken once daily

Primary outcomes

  1. HbA1c Change From Baseline at Week 12

    Time frame: Baseline and Week 12

    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.

Secondary outcomes

  1. HbA1c Change From Baseline at Week 52

    Time frame: Baseline and Week 52

    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.

  2. HbA1c Change From Baseline at Week 18

    Time frame: Baseline and Week 18

    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.

  3. HbA1c Change From Baseline at Week 24

    Time frame: Baseline and Week 24

    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.

  4. HbA1c Change From Baseline at Week 30

    Time frame: Baseline and Week 30

    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.

  5. HbA1c Change From Baseline at Week 36

    Time frame: Baseline and Week 36

    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.

  6. HbA1c Change From Baseline at Week 42

    Time frame: Baseline and Week 42

    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.

  7. HbA1c Change From Baseline at Week 48

    Time frame: Baseline and Week 48

    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.

  8. 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

    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%

  9. 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

    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%.

  10. Percentage of Patients With HbA1c Lowering by 0.5% at Week 52

    Time frame: Baseline and Week 52

    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).

  11. FPG Change From Baseline at Week 12

    Time frame: Baseline and Week 12

    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

  12. FPG Change From Baseline at Week 18

    Time frame: Baseline and Week 18

    Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs

  13. FPG Change From Baseline at Week 24

    Time frame: Baseline and Week 24

    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

  14. FPG Change From Baseline at Week 30

    Time frame: Baseline and Week 30

    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

  15. FPG Change From Baseline at Week 36

    Time frame: Baseline and Week 36

    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

  16. FPG Change From Baseline at Week 42

    Time frame: Baseline and Week 42

    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

  17. FPG Change From Baseline at Week 48

    Time frame: Baseline and Week 48

    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

  18. FPG Change From Baseline at week52

    Time frame: Baseline and Week 52

    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

  19. Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time

    Time frame: Baseline and Week 52

    Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.

  20. Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG

    Time frame: first administration of randomised treatment to ....

    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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive

Important dates

Study start
2008
Primary completion
2011
First posted
Dec 2, 2008
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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