Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Glimepiride
Drug: Linagliptin

Registration Number: NCT01087502

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin	Placebo	52 weeks treatment
Linagliptin	Linagliptin	52 weeks treatment
Placebo	Placebo	First 12 weeks of treatment
Glimepiride	Glimepiride	Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
Glimepiride	Placebo	Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline to Week 12	Baseline and 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, renal function impairment and prior use of antidiabetic agents.

Secondary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline Over Time	Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52	HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.
Fasting Plasma Glucose (FPG) Change From Baseline to Week 12	Baseline and 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 prior use of insulin, week repeated within patient and week by treatment interaction.
Fasting Plasma Glucose (FPG) Change From Baseline Over Time	Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52	This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.
Percentage of Patients With HbA1c <7.0%	Baseline, week 12 and week 52	The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5%	Baseline, week 12 and week 52	The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.
Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%	Baseline, week 12 and week 52	The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.
Plasma Concentration of Linagliptin at Trough	Week 12, 24 and 52	Trough levels of concentration of Linagliptin in plasma.

Trial Locations

Locations (52): 1218.64.61002 Boehringer Ingelheim Investigational Site
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St Leonards, New South Wales, Australia
1218.64.20007 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1218.64.20008 Boehringer Ingelheim Investigational Site
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Corunna, Ontario, Canada
1218.64.20005 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1218.64.10004 Boehringer Ingelheim Investigational Site
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Flint, Michigan, United States
1218.64.10018 Boehringer Ingelheim Investigational Site
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Pembroke Pines, Florida, United States
1218.64.10016 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, United States
1218.64.10002 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
1218.64.10011 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1218.64.10020 Boehringer Ingelheim Investigational Site
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Philadelphia, Pennsylvania, United States
1218.64.10014 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1218.64.10008 Boehringer Ingelheim Investigational Site
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Pittsburgh, Pennsylvania, United States
1218.64.10009 Boehringer Ingelheim Investigational Site
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Arlington, Texas, United States
1218.64.10005 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1218.64.61001 Boehringer Ingelheim Investigational Site
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Liverpool, New South Wales, Australia
1218.64.61003 Boehringer Ingelheim Investigational Site
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Adelaide, South Australia, Australia
1218.64.20004 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1218.64.20003 Boehringer Ingelheim Investigational Site
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Point Claire, Quebec, Canada
1218.64.35803 Boehringer Ingelheim Investigational Site
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Oulu, Finland
1218.64.35801 Boehringer Ingelheim Investigational Site
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Turku, Finland
1218.64.81006 Boehringer Ingelheim Investigational Site
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Isesaki, Gunma, Japan
1218.64.97201 Boehringer Ingelheim Investigational Site
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Jerusalem, Israel
1218.64.81001 Boehringer Ingelheim Investigational Site
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Meguro-ku, Tokyo, Japan
1218.64.42108 Boehringer Ingelheim Investigational Site
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Trencin, Slovakia
1218.64.20009 Boehringer Ingelheim Investigational Site
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Stayner, Ontario, Canada
1218.64.10010 Boehringer Ingelheim Investigational Site
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Tacoma, Washington, United States
1218.64.10007 Boehringer Ingelheim Investigational Site
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Chula Vista, California, United States
1218.64.10015 Boehringer Ingelheim Investigational Site
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Boise, Idaho, United States
1218.64.10013 Boehringer Ingelheim Investigational Site
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Philadelphia, Pennsylvania, United States
1218.64.10003 Boehringer Ingelheim Investigational Site
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Bronx, New York, United States
1218.64.61005 Boehringer Ingelheim Investigational Site
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Gosford, New South Wales, Australia
1218.64.97203 Boehringer Ingelheim Investigational Site
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Haifa, Israel
1218.64.81007 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japan
1218.64.81002 Boehringer Ingelheim Investigational Site
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Shinjyuku-ku,Tokyo, Japan
1218.64.81004 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Japan
1218.64.81003 Boehringer Ingelheim Investigational Site
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Suwa, Nagano, Japan
1218.64.42107 Boehringer Ingelheim Investigational Site
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Kosice, Slovakia
1218.64.42109 Boehringer Ingelheim Investigational Site
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Nitra, Slovakia
1218.64.64001 Boehringer Ingelheim Investigational Site
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Otahuhu Auckland, New Zealand
1218.64.46002 Boehringer Ingelheim Investigational Site
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Härnösand, Sweden
1218.64.46003 Boehringer Ingelheim Investigational Site
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Helsingborg, Sweden
1218.64.10006 Boehringer Ingelheim Investigational Site
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Kansas City, Missouri, United States
1218.64.20002 Boehringer Ingelheim Investigational Site
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Sarnia, Ontario, Canada
1218.64.35804 Boehringer Ingelheim Investigational Site
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Kokkola, Finland
1218.64.61004 Boehringer Ingelheim Investigational Site
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Reservoir, Victoria, Australia
1218.64.97204 Boehringer Ingelheim Investigational Site
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Ashkelon, Israel
1218.64.97202 Boehringer Ingelheim Investigational Site
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Nahariya, Israel
1218.64.97206 Boehringer Ingelheim Investigational Site
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Tel Aviv, Israel
1218.64.81005 Boehringer Ingelheim Investigational Site
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Asahi, Chiba, Japan
1218.64.97207 Boehringer Ingelheim Investigational Site
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Givatayim, Israel
1218.64.81008 Boehringer Ingelheim Investigational Site
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Nagoya, Aichi, Japan
1218.64.42102 Boehringer Ingelheim Investigational Site
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Bratislava, Slovakia