Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
| Status | Completed |
| Enrollment | 333 |
| Est. completion date | |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 75 Years |
| Eligibility |
Inclusion criteria: Inclusion_Criteria: - Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug - HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug - HbA1c 7.5 10.0% at screening for patients treated with metformin alone - HbA1c 7.5 10.0% at beginning of the placebo run-in phase - Age > 21 and < 75 years - MI > 25 and < 40 kg/m2 (Body Mass Index) Exclusion criteria: Exclusion_Criteria: - Clinically relevant cardiovascular disease - Impaired hepatic function - Renal insufficiency or impaired renal function - Treatment with rosiglitazone or pioglitazone within 6 months prior to screening - Treatment with insulin within 3 months prior to screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | 1218.6.3304A Boehringer Ingelheim Investigational Site | Joue les Tours | |
| France | 1218.6.3305A Euraxi Pharma | Joue les Tours | |
| France | 1218.6.3302A Boehringer Ingelheim Investigational Site | Joué les Tours | |
| France | 1218.6.3303A Boehringer Ingelheim Investigational Site | Joué Les Tours | |
| France | 1218.6.3301A Boehringer Ingelheim Investigational Site | Paris cedex 13 | |
| Germany | 1218.6.49007 Boehringer Ingelheim Investigational Site | Aschaffenburg | |
| Germany | 1218.6.49013 Boehringer Ingelheim Investigational Site | Bosenheim | |
| Germany | 1218.6.49008 Boehringer Ingelheim Investigational Site | Dresden | |
| Germany | 1218.6.49009 Boehringer Ingelheim Investigational Site | Düsseldorf | |
| Germany | 1218.6.49014 Boehringer Ingelheim Investigational Site | Heidelberg | |
| Germany | 1218.6.49012 Boehringer Ingelheim Investigational Site | Immenstadt | |
| Germany | 1218.6.49001 Boehringer Ingelheim Investigational Site | Mainz | |
| Germany | 1218.6.49005 Boehringer Ingelheim Investigational Site | Neuwied | |
| Germany | 1218.6.49017 Boehringer Ingelheim Investigational Site | Offenbach a. M. | |
| Germany | 1218.6.49002 Boehringer Ingelheim Investigational Site | Saarbrücken | |
| Germany | 1218.6.49011 Boehringer Ingelheim Investigational Site | Sinsheim | |
| Germany | 1218.6.49010 Boehringer Ingelheim Investigational Site | St. Ingbert/Oberwürzbach | |
| Germany | 1218.6.49015 Boehringer Ingelheim Investigational Site | Sulzbach-Rosenberg | |
| Germany | 1218.6.49016 Boehringer Ingelheim Investigational Site | Wangen | |
| Germany | 1218.6.49003 Boehringer Ingelheim Investigational Site | Würzburg | |
| Slovakia | 1218.6.42103 Boehringer Ingelheim Investigational Site | Banska Bystrica | |
| Slovakia | 1218.6.42104 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 1218.6.42105 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 1218.6.42101 Boehringer Ingelheim Investigational Site | Nove Mesto nad Vahom | |
| Sweden | 1218.6.46003 Boehringer Ingelheim Investigational Site | Göteborg | |
| Sweden | 1218.6.46001 Boehringer Ingelheim Investigational Site | Malmö | |
| Sweden | 1218.6.46002 Boehringer Ingelheim Investigational Site | Uddevalla | |
| Sweden | 1218.6.46004 Boehringer Ingelheim Investigational Site | Uppsala | |
| Ukraine | 1218.6.38002 Boehringer Ingelheim Investigational Site | Dnyepropetrovsk | |
| Ukraine | 1218.6.38001 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1218.6.38003 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1218.6.38005 Boehringer Ingelheim Investigational Site | Kiev | |
| United Kingdom | 1218.6.44012 Boehringer Ingelheim Investigational Site | Ashford | |
| United Kingdom | 1218.6.44004 Boehringer Ingelheim Investigational Site | Baillieston, Glasgow | |
| United Kingdom | 1218.6.44002 Boehringer Ingelheim Investigational Site | Bath | |
| United Kingdom | 1218.6.44003 Boehringer Ingelheim Investigational Site | Birmingham | |
| United Kingdom | 1218.6.44013 Boehringer Ingelheim Investigational Site | Camberley | |
| United Kingdom | 1218.6.44016 Boehringer Ingelheim Investigational Site | Chorley | |
| United Kingdom | 1218.6.44007 Boehringer Ingelheim Investigational Site | Dundee | |
| United Kingdom | 1218.6.44006 Boehringer Ingelheim Investigational Site | Exeter | |
| United Kingdom | 1218.6.44005 Boehringer Ingelheim Investigational Site | Gillingham | |
| United Kingdom | 1218.6.44015 Boehringer Ingelheim Investigational Site | Glasgow | |
| United Kingdom | 1218.6.44008 Boehringer Ingelheim Investigational Site | Guildford | |
| United Kingdom | 1218.6.44017 Boehringer Ingelheim Investigational Site | Liverpool | |
| United Kingdom | 1218.6.44001 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1218.6.44018 Boehringer Ingelheim Investigational Site | Manchester | |
| United Kingdom | 1218.6.44009 Boehringer Ingelheim Investigational Site | Newcastle upon Tyne | |
| United Kingdom | 1218.6.44019 Boehringer Ingelheim Investigational Site | Reading |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
France, Germany, Slovakia, Sweden, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c Change From Baseline at Week 12 | HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c. | Baseline and week 12 | No |
| Secondary | Percentage of Patients With HbA1c<=7.0% at Week 12 | Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12. | week 12 | No |
| Secondary | Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at 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 previous anti-diabetic medication. | Baseline and week 12 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |