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

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 1356 Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Linagliptin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.
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.
Percentage of Patients With HbA1c < 6.5% at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
The percentage of patients with an HbA1c value below 6.5% at week 12 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Percentage of Patients With HbA1c <7.0% at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
The percentage of patients with an HbA1c value below 7.0% at week 12 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 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 12 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.

Enrollment:	133
Study Start Date:	December 2008
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 1356 patient to receive a tablet containing BI 1356 once daily	Drug: BI 1356 BI 1356 dosed once daily
Placebo Comparator: placebo patient to receive a tablet identical to BI 1356 once daily	Drug: placebo placebo matching BI 1356 taken once daily

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800683

Show 53 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00800683 History of Changes
Other Study ID Numbers:	1218.43, 2008-001569-27
Study First Received:	December 1, 2008
Results First Received:	December 30, 2011
Last Updated:	February 13, 2013
Health Authority:	Australia: Dept of Health and Ageing Therapeutic Goods Admin Hong Kong: Department of Health Israel: Ministry of Health New Zealand: Medsafe Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

BI 1356
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013