Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328172
• Other study ID #: 1218.5
• Status: Completed
• Phase: Phase 2
• First received: May 18, 2006
• Last updated: February 15, 2014
• Start date: May 2006

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Responsilble Ethics CommitteeCanada: Health Canada (TPD)Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10Russia: Ministry of Healthcare and Social Development of Russian Federation, MoscowUkraine: Ministry of Health Care of Ukraine (MoH of Ukraine)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion criteria:

1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.

2. Diagnosis of Type 2 diabetes with duration of at least 3 months

3. Glycosylated haemoglobin A1 (HbA1c) of:

7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)

4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).

5. Age >=21 and <=75 years.

6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.

7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)

2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal

3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening

4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial

5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)

6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)

7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening

8. Treatment with insulin within 3 months prior to screening

9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)

10. Participation in another trial with an investigational drug within two months prior to administration or during the trial

11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)

12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

1. are not surgically sterile,

2. or are nursing or pregnant;

3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.

13. Intolerance of metformin

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Placebo matching BI 1356
• BI 1356 dose 3 once daily
BI 1356 dose 3 once daily
• BI 1356 dose 2 once daily
BI 1356 dose 2 once daily
• BI 1356 dose 1 once daily
BI 1356 dose 1 once daily
• Metformin
Metformin

Locations

Country	Name	City	State
Australia	1218.5.61005 Boehringer Ingelheim Investigational Site	Box Hill	Victoria
Australia	1218.5.61006 Boehringer Ingelheim Investigational Site	Dandenong	Victoria
Australia	1218.5.61007 Boehringer Ingelheim Investigational Site	East Ringwood	Victoria
Australia	1218.5.61004 Boehringer Ingelheim Investigational Site	Fremantle	Western Australia
Australia	1218.5.61001 Boehringer Ingelheim Investigational Site	Miranda	New South Wales
Australia	1218.5.61002 Boehringer Ingelheim Investigational Site	Nedlands	Western Australia
Canada	1218.5.11011 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1218.5.11016 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	1218.5.11005 Boehringer Ingelheim Investigational Site	Hamilton	Ontario
Canada	1218.5.11006 Boehringer Ingelheim Investigational Site	Montague	Prince Edward Island
Canada	1218.5.11014 Boehringer Ingelheim Investigational Site	Oakville	Ontario
Canada	1218.5.11010 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	1218.5.11003 Boehringer Ingelheim Investigational Site	Red Deer	Alberta
Canada	1218.5.11017 Boehringer Ingelheim Investigational Site	Sainte-Foy	Quebec
Canada	1218.5.11009 Boehringer Ingelheim Investigational Site	Sarnia	Ontario
Canada	1218.5.11018 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	1218.5.11012 Boehringer Ingelheim Investigational Site	Thornhill	Ontario
Canada	1218.5.11002 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	1218.5.11004 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1218.5.11013 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia
Canada	1218.5.11015 Boehringer Ingelheim Investigational Site	Winnipeg	Manitoba
Czech Republic	1218.5.42002 Boehringer Ingelheim Investigational Site	Olomouc 9
Czech Republic	1218.5.42003 Boehringer Ingelheim Investigational Site	Praha 4
Czech Republic	1218.5.42005 Boehringer Ingelheim Investigational Site	Praha 4
Czech Republic	1218.5.42004 Boehringer Ingelheim Investigational Site	Praha 9
Czech Republic	1218.5.42001 Boehringer Ingelheim Investigational Site	Sternberk
Russian Federation	1218.5.70001 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1218.5.70002 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1218.5.70003 Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	1218.5.70004 Boehringer Ingelheim Investigational Site	St. Petersburg
Russian Federation	1218.5.70005 Boehringer Ingelheim Investigational Site	St. Petersburg
Ukraine	1218.5.38005 Boehringer Ingelheim Investigational Site	Kharkov
Ukraine	1218.5.38001 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1218.5.38002 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1218.5.38003 Boehringer Ingelheim Investigational Site	Kiev
Ukraine	1218.5.38004 Boehringer Ingelheim Investigational Site	Lvov
Ukraine	1218.5.38006 Boehringer Ingelheim Investigational Site	Vinnitsa
United States	1218.5.10042 Boehringer Ingelheim Investigational Site	Albany	New York
United States	1218.5.10039 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	1218.5.10034 Boehringer Ingelheim Investigational Site	Butte	Montana
United States	1218.5.10025 Boehringer Ingelheim Investigational Site	Chesterfield	Missouri
United States	1218.5.10020 Boehringer Ingelheim Investigational Site	Chula Vista	California
United States	1218.5.10044 Boehringer Ingelheim Investigational Site	Columbia	South Carolina
United States	1218.5.10026 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	1218.5.10006 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1218.5.10041 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	1218.5.10029 Boehringer Ingelheim Investigational Site	Endwell	New York
United States	1218.5.10022 Boehringer Ingelheim Investigational Site	Federal Way	Washington
United States	1218.5.10033 Boehringer Ingelheim Investigational Site	Greer	South Carolina
United States	1218.5.10018 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	1218.5.10040 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	1218.5.10017 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana
United States	1218.5.10016 Boehringer Ingelheim Investigational Site	Jacksonville	Florida
United States	1218.5.10001 Boehringer Ingelheim Investigational Site	La Jolla	California
United States	1218.5.10023 Boehringer Ingelheim Investigational Site	Medford	Oregon
United States	1218.5.10035 Boehringer Ingelheim Investigational Site	Mentor	Ohio
United States	1218.5.10003 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1218.5.10011 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	1218.5.10004 Boehringer Ingelheim Investigational Site	New Hyde Park	New York
United States	1218.5.10009 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	1218.5.10012 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	1218.5.10030 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	1218.5.10014 Boehringer Ingelheim Investigational Site	Renton	Washington
United States	1218.5.10027 Boehringer Ingelheim Investigational Site	Salem	Virginia
United States	1218.5.10036 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	1218.5.10038 Boehringer Ingelheim Investigational Site	Simpsonville	South Carolina
United States	1218.5.10032 Boehringer Ingelheim Investigational Site	Springfield	Massachusetts
United States	1218.5.10008 Boehringer Ingelheim Investigational Site	Topeka	Kansas
United States	1218.5.10021 Boehringer Ingelheim Investigational Site	Tyler	Texas
United States	1218.5.10007 Boehringer Ingelheim Investigational Site	Walnut Creek	California
United States	1218.5.10024 Boehringer Ingelheim Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12	The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.	Baseline, week 12	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG.	Baseline, week 12	No
Secondary	Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks	An absolute efficacy response is defined as HbA1c <= 7.0% at 12 weeks. A non-response is defined as HbA1c > 7.0% at 12 weeks.	Baseline, week 12	No

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