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

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2012-05
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-08-12
• Results First Posted: 2013-10-17
• Status Verified: 2014-05
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

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)

1218.64.10007 Boehringer Ingelheim Investigational Site; 🇺🇸 Chula Vista, California, United States

1218.64.10018 Boehringer Ingelheim Investigational Site; 🇺🇸 Pembroke Pines, Florida, United States

1218.64.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Decatur, Georgia, United States

1218.64.10015 Boehringer Ingelheim Investigational Site; 🇺🇸 Boise, Idaho, United States

1218.64.10002 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

1218.64.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Flint, Michigan, United States

1218.64.10006 Boehringer Ingelheim Investigational Site; 🇺🇸 Kansas City, Missouri, United States

1218.64.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Bronx, New York, United States

1218.64.10013 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

1218.64.10020 Boehringer Ingelheim Investigational Site; 🇺🇸 Philadelphia, Pennsylvania, United States

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