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

NCT01087502 | Completed Phase 3 Results

• 2 other identifiers: 1218.642009-016971-31
• Study Type: interventional
• Target: 241
• Locations: 9 countries
• Sites: 52

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline to 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.

  Baseline and week 12

Secondary Outcomes (7)

• 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

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

  Baseline and week 12

• 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

• Percentage of Patients With HbA1c <7.0%

  Baseline, week 12 and week 52

• Percentage of Patients With HbA1c <6.5%

  Baseline, week 12 and week 52

Study Arms (3)

Linagliptin

EXPERIMENTAL

52 weeks treatment

Drug: Placebo; Drug: Linagliptin

Placebo

PLACEBO COMPARATOR

First 12 weeks of treatment

Drug: Placebo

Glimepiride

ACTIVE COMPARATOR

Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)

Drug: Glimepiride; Drug: Placebo

Interventions

Glimepiride DRUG

1-4 mg daily after 12 weeks

Glimepiride

Placebo DRUG

Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily

Placebo

Linagliptin DRUG

5 mg once daily

Linagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus
• GFR\<60 ml/min
• HbA1c \>=7.0% to \<= 10%
• Age \>= 18 years
• BMI \<=45 kg/m2
• Signed and dated written informed consent

You may not qualify if:

• Myocardial infarction, stroke or TIA within 3 months prior to informed consent
• Renal impairment requiring dialysis
• Bariatric surgery
• Impaired hepatic function
• Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors
• Treatment with anti-obesity drugs
• Treatment with SU, glinides and metformin 8 weeks prior to informed consent

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (52)

1218.64.10007 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

Location

1218.64.10018 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1218.64.10016 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1218.64.10015 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

Location

1218.64.10002 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1218.64.10004 Boehringer Ingelheim Investigational Site

Flint, Michigan, United States

Location

1218.64.10006 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

1218.64.10003 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

1218.64.10013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.64.10020 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1218.64.10008 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1218.64.10009 Boehringer Ingelheim Investigational Site

Arlington, Texas, United States

Location

1218.64.10005 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1218.64.10011 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.64.10014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1218.64.10010 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1218.64.61005 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Location

1218.64.61001 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Location

1218.64.61002 Boehringer Ingelheim Investigational Site

St Leonards, New South Wales, Australia

Location

1218.64.61003 Boehringer Ingelheim Investigational Site

Adelaide, South Australia, Australia

Location

1218.64.61004 Boehringer Ingelheim Investigational Site

Reservoir, Victoria, Australia

Location

1218.64.20008 Boehringer Ingelheim Investigational Site

Corunna, Ontario, Canada

Location

1218.64.20005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.64.20007 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1218.64.20002 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Location

1218.64.20009 Boehringer Ingelheim Investigational Site

Stayner, Ontario, Canada

Location

1218.64.20004 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1218.64.20003 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Location

1218.64.35804 Boehringer Ingelheim Investigational Site

Kokkola, Finland

Location

1218.64.35803 Boehringer Ingelheim Investigational Site

Oulu, Finland

Location

1218.64.35801 Boehringer Ingelheim Investigational Site

Turku, Finland

Location

1218.64.97204 Boehringer Ingelheim Investigational Site

Ashkelon, Israel

Location

1218.64.97207 Boehringer Ingelheim Investigational Site

Giv‘atayim, Israel

Location

1218.64.97203 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1218.64.97201 Boehringer Ingelheim Investigational Site

Jerusalem, Israel

Location

1218.64.97202 Boehringer Ingelheim Investigational Site

Nahariya, Israel

Location

1218.64.97206 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1218.64.81005 Boehringer Ingelheim Investigational Site

Asahi, Chiba, Japan

Location

1218.64.81006 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, Japan

Location

1218.64.81001 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, Japan

Location

1218.64.81008 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1218.64.81007 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1218.64.81002 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, Japan

Location

1218.64.81004 Boehringer Ingelheim Investigational Site

Suita, Osaka, Japan

Location

1218.64.81003 Boehringer Ingelheim Investigational Site

Suwa, Nagano, Japan

Location

1218.64.64001 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, New Zealand

Location

1218.64.42102 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1218.64.42107 Boehringer Ingelheim Investigational Site

Košice, Slovakia

Location

1218.64.42109 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1218.64.42108 Boehringer Ingelheim Investigational Site

Trenčín, Slovakia

Location

1218.64.46002 Boehringer Ingelheim Investigational Site

Härnösand, Sweden

Location

1218.64.46003 Boehringer Ingelheim Investigational Site

Helsingborg, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2012
• Last Updated: June 27, 2014
• Results First Posted: October 17, 2013

Record last verified: 2014-05

Locations

NZ (1); FI (3); AU (5); JP (8); US (16); CA (7); SE (2); IL (6); SL (4)