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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Glimepiride (Drug); Placebo (Drug); Placebo (Drug); Placebo (Drug); Linagliptin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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).

Clinical Details

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: HbA1c Change From Baseline to Week 12

Secondary outcome:

HbA1c Change From Baseline Over Time

Fasting Plasma Glucose (FPG) Change From Baseline to Week 12

Fasting Plasma Glucose (FPG) Change From Baseline Over Time

Percentage of Patients With HbA1c <7.0%

Percentage of Patients With HbA1c <6.5%

Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%

Plasma Concentration of Linagliptin at Trough

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Type 2 diabetes mellitus 2. GFR<60 ml/min 3. HbA1c >=7. 0% to <= 10% 4. Age >= 18 years 5. BMI <=45 kg/m2 6. Signed and dated written informed consent Exclusion criteria: 1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent 2. Renal impairment requiring dialysis 3. Bariatric surgery 4. Impaired hepatic function 5. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors 6. Treatment with anti-obesity drugs 7. Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Locations and Contacts

1218.64.35804 Boehringer Ingelheim Investigational Site, Kokkola, Finland

1218.64.35803 Boehringer Ingelheim Investigational Site, Oulu, Finland

1218.64.35801 Boehringer Ingelheim Investigational Site, Turku, Finland

1218.64.97204 Boehringer Ingelheim Investigational Site, Ashkelon, Israel

1218.64.97207 Boehringer Ingelheim Investigational Site, Givatayim, Israel

1218.64.97203 Boehringer Ingelheim Investigational Site, Haifa, Israel

1218.64.97201 Boehringer Ingelheim Investigational Site, Jerusalem, Israel

1218.64.97202 Boehringer Ingelheim Investigational Site, Nahariya, Israel

1218.64.97206 Boehringer Ingelheim Investigational Site, Tel Aviv, Israel

1218.64.81005 Boehringer Ingelheim Investigational Site, Asahi, Chiba, Japan

1218.64.81006 Boehringer Ingelheim Investigational Site, Isesaki, Gunma, Japan

1218.64.81001 Boehringer Ingelheim Investigational Site, Meguro-ku, Tokyo, Japan

1218.64.81008 Boehringer Ingelheim Investigational Site, Nagoya, Aichi, Japan

1218.64.81007 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan

1218.64.81002 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan

1218.64.81004 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan

1218.64.81003 Boehringer Ingelheim Investigational Site, Suwa, Nagano, Japan

1218.64.64001 Boehringer Ingelheim Investigational Site, Otahuhu Auckland, New Zealand

1218.64.42102 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1218.64.42107 Boehringer Ingelheim Investigational Site, Kosice, Slovakia

1218.64.42109 Boehringer Ingelheim Investigational Site, Nitra, Slovakia

1218.64.42108 Boehringer Ingelheim Investigational Site, Trencin, Slovakia

1218.64.46003 Boehringer Ingelheim Investigational Site, Helsingborg, Sweden

1218.64.46002 Boehringer Ingelheim Investigational Site, Härnösand, Sweden

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

1218.64.61005 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia

1218.64.61001 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia

1218.64.61002 Boehringer Ingelheim Investigational Site, St Leonards, New South Wales, Australia

1218.64.10003 Boehringer Ingelheim Investigational Site, Bronx, New York, United States

1218.64.20008 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada

1218.64.20005 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada

1218.64.20007 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada

1218.64.20002 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada

1218.64.20009 Boehringer Ingelheim Investigational Site, Stayner, Ontario, Canada

1218.64.20004 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada

1218.64.10013 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

1218.64.10020 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

1218.64.10008 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States

1218.64.20003 Boehringer Ingelheim Investigational Site, Point Claire, Quebec, Canada

1218.64.61003 Boehringer Ingelheim Investigational Site, Adelaide, South Australia, Australia

1218.64.10009 Boehringer Ingelheim Investigational Site, Arlington, Texas, United States

1218.64.10005 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

1218.64.10011 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1218.64.10014 Boehringer Ingelheim Investigational Site, Houston, Texas, United States

1218.64.61004 Boehringer Ingelheim Investigational Site, Reservoir, Victoria, Australia

1218.64.10010 Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States

Additional Information

Starting date: March 2010
Last updated: June 17, 2014

Page last updated: August 23, 2015

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